Drug Injury Attorney Blog

Another Johnson & Johnson drug manufacturing plant operated by McNeil has received notice of problems with its manufacturing practices from the FDA. The Lancaster, Pennsylvania plant makes the heartburn and gas relief drugs Pepcid, Imodium and Mylanta. These problems, similar to those found in the company's now closed plant that made Tylenol, come after waves of recalls for defective medications and a congressional investigation into whether the company attempted to hide information from the FDA. As a defective medication lawyer, I believe this news underscores questions about how much consumers should trust medications produced by Johnson & Johnson and its McNeil division. These repeated problems could prompt concerns about any of the company’s many over-the-counter medications.

In July, the FDA issued a Form 483 to Johnson & Johnson about the Lancaster plant. A Form 483 notifies a company that the FDA has found lapses in its manufacturing practices. Of the 12 violations of good manufacturing practices that the FDA found in Lancaster -- including faulty lab work, lax hygiene and recordkeeping, and failure to follow up on consumer complaints -- five overlapped with those cited at the Tylenol plant in nearby Fort Washington, Pennsylvania. The medications from the Lancaster plant were the subject of several kinds of complaints from consumers, including "mint-flavored Pepcid tablets mixed inside the same bottle as berry-flavored tablets" and "lack of effect" in one lot of products. In addition, the FDA report cited "unlabeled test tubes filled with product sitting out on a counter" and failure to "properly clean utensils used in the drug making process," suggesting that medications could become contaminated with foreign substances or with other medications. Staff at the manufacturing plant did not follow up to investigate and correct any of these problems, the FDA report said.

Since they did not follow up on the problems, staff at the plant would have been unable to find out whether there were serious safety concerns that consumers needed to know about. In my view as adangerous medication attorney, this is troubling from a consumer safety standpoint as well as legally, since drug manufacturers are responsible for warning consumers about any safety concerns related to their products. Consumers should continue to be wary of medications produced by Johnson & Johnson. If only one plant had these problems, we might be able to dismiss them as isolated to bad management at one site, but the problem appears to be much more widespread. Even though the medications manufactured at the Lancaster plant have not been recalled, a recall may still be coming. After all, the recalls involving the Fort Washington plant's medications were delayed in similar ways and have only gotten bigger as time has gone on.

These issues raise the question of what Johnson & Johnson has been doing instead of paying attention to its manufacturing practices. Have efforts to create new products or expand existing products' reach edged out the basic safety concerns that should be at the forefront of any medical manufacturing business's operations? Or, worse, could the company have intentionally ignored problems in order to avoid bad publicity? Ignoring safety for any reason would be dangerous, legally and morally. Consumers can be hurt by lax manufacturing practices, as KV Pharmaceutical here in St. Louis found out. And those who were hurt have the right to recover financial compensation from the defective product's manufacturer. Drug manufacturers who fail to warn consumers of risks that they know about can be liable in lawsuits filed by those consumers. This allows a consumer who incurs medical costs, misses work or is unable to work, or whose quality of life suffers because of harm caused by an over-the-counter or prescription drug to require the drug manufacturer to pay these costs.

Continue reading "Another Johnson & Johnson Drug Manufacturing Plant Cited for Safety Failures" »

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Doctors and patients are worried about whether the diabetes drug Avandia (rosiglitazone) is safe, as I've discussed on several occasions this year from my perspective as a dangerous prescription medication lawyer. Avandia has been associated in several studies with a marked increase in heart problems, including life-threatening heart failure. But a recent report from MedPage Today suggests that FDA seems determined not to take this drug off the market, despite those studies. An FDA advisory committee voted 20-12 in favor of keeping Avandia on the market, but 17 of the supporters wanted the drug to carry tougher warning labels. Avandia already has a black box warning, the FDA's strongest warning of a drug's risks, advising patients that it increases the risk of heart failure. So it's not clear how much good another warning label about risks of heart problems would do to prevent patients from being harmed by Avandia. As Joel Zonszein, MD, of Albert Einstein College of Medicine said, "The physician is left in limbo" by this decision.

Speaking as a href="http://www.jefflowepc.com/lawyer-attorney-1176136.html">pharmaceutical liability attorney, I believe it's good that FDA staff members and advisors are debating Avandia's risks, because that makes it more likely that they'll consider all relevant viewpoints. However, Thomas Marciniak, MD, an FDA staff reviewer, said that the debate over Avandia has turned into a turf battle between the drug's supporters and detractors, with some newcomers to the agency in the middle. Marciniak said higher-ups at the FDA reward positive assessments of drugs, while negative assessments lead to "endless meetings." Another FDA staff reviewer, David Graham, MD, pointed out that the members of the FDA advisory panel voting on Avandia's fate seemed to have been chosen to ensure a favorable outcome for Avandia. In addition, Graham alleged that higher-ups at the FDA leaked information to a popular medical blog about an Avandia study he had conducted in order to delay or prevent the study's publication.

It's unclear why the FDA wants to keep Avandia on the market, but it’s clear why GlaxoSmithKline, Avandia's maker, might be interested in doing so. We’ve already seen that the company is deeply invested in protecting Avandia. It's a profitable drug, and type 2 diabetes rates have been drastically increasing along with obesity rates. Obesity is considered a leading cause of type 2 diabetes. This means that GlaxoSmithKline stands to rake in increasing profits from Avandia as an increasing number of people need treatment for type 2 diabetes. From my perspective as a defective drug lawyer, this only adds to the questions about why the FDA seems to be protecting Avandia's place on the market.

Continue reading "FDA Dysfunction Leaves Avandia-Taking Patients to Watch Out for Their Own Safety" »

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In the last few months I've kept tabs on medications recalled for quality control problems by McNeil Pharmaceuticals, as well as McNeil's parent company Johnson & Johnson's recalls of medications that were "musty-smelling." Unfortunately for consumers who thought their medicine cabinets were finally safe, the musty medications have apparently still been in production. Johnson & Johnson recalled 500,000 bottles of potentially contaminated Benadryl and Extra Strength Tylenol on June 15, and on July 9 it recalled another 2.5 million bottles of medications, including Tylenol for children and adults, Benadryl allergy tablets and Motrin (ibuprofen). As a defective medication lawyer, I'm concerned about what this growing list of recalled medicines could mean for consumers, who need to know which medications are safe for them to depend on and which ones could injure or kill them.

The latest recall involves medications that smell moldy or musty because they have been in contact with 2,4,6-tribromoanisole, or TBA, a pesticide and flame retardant chemical used in pallets for shipping and storing the medicines. According to Consumer Reports, people have reported "experiencing nausea, stomach pain, vomiting or diarrhea after taking the contaminated medications." Beyond those symptoms, the longer-term health ramifications of exposure to TBA are unclear. The medications recalled in July actually represent an expansion of the late 2009 recall; they were belatedly discovered to have been part of the same group of medications. Consumer Reports did not mention a reason for the months-long delay.

It's important to point out, from my point of view as pharmaceutical liability attorney, that there are two different kinds of problems being addressed by these recalls. That means that there's not just one thing going wrong in Johnson & Johnson's manufacturing plants, but a whole series of problems. While the November-January, June and July recalls relate to TBA contamination, the April and May recalls by McNeil relate to metal particles present in medications. There's also the serious issue of McNeil's having delayed informing the FDA of the problems until a year after the company knew about them.

The U.S. House Oversight and Government Reform Committee launched an investigation after the McNeil recalls were issued on April 30 to look into what Representative Edolphus Towns, D-NY, chairman of the oversight committee, called "wide-ranging problems at Johnson & Johnson.” This investigation might help protect consumers and get to the bottom of what caused 775 instances of "serious side effects" related to recalled McNeil drugs, including 30 deaths.

Consumers should not have to wonder whether they're better off suffering through a headache or allergies or taking an over-the-counter medication that could make them feel even worse. That's why the law requires drug manufacturers to warn consumers when their products aren't safe to use as intended. As we've seen, McNeil and Johnson & Johnson have a spotty record of complying with that requirement. But consumers don't have to just rely on the FDA to send warning letters and fix the problem from the top down. If a defective over-the-counter medication hurts someone who took it -- expecting that it would be safe -- that person can fight back against the drug manufacturer who failed to warn consumers of the drug's potential danger. The victim can sue the manufacturer for financial compensation for their injuries.

Continue reading "Johnson & Johnson, McNeil Drugs Continue to Be Investigated and Recalled for Safety" »

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Diabetics should take note of two newly published studies that confirm existing evidence that the diabetes drug Avandia (rosiglitazone) increases the risk of heart attacks as well as heart failure. As a defective drug injury attorney, I've been closely following the news about Avandia this year. In February, the disturbing findings of the Senate Finance Committee that GlaxoSmithKline, Avandia's manufacturer, made claims it knew were misleading about the drug's safety. In April, the FDA considered ending a study of Avandia early because it was unethical to expose patients to a 64% greater chance that they could have a heart attack associated with the drug. Now, the Consumer Reports Insights column in the Washington Post is advising diabetics to opt for the older diabetes medicine metformin over Avandia, because two more studies have just shown that Avandia increases the risk of heart attack, stroke, heart failure and death.

Avandia already carries a black box warning, the FDA's strongest warning, that lets patients know the drug has been associated with heart failure. But in light of the two newly published studies, FDA regulators are questioning whether Avandia should be pulled off the market entirely because of its association with heart attacks. In one of the studies, published in the Archives of Internal Medicine, Dr. Steven Nissen of the Cleveland Clinic added 14 more studies to the 42 on which he performed a meta-analysis. This expanded and updated analysis confirmed his 2007 finding that taking Avandia increases the risk of heart attack. The Journal of the American Medical Association published another study, by the FDA's David Graham and others, that found that taking Avandia increased the risk of stroke, heart failure and death. Graham and his colleagues' study was based on their analysis of more than 227,000 Medicare records for patients taking Avandia or Actos (another diabetes drug).

From my perspective as a dangerous prescription drug injury lawyer, it's worrisome that so many patients' lives and health remain at risk while GlaxoSmithKline continues to deny what many studies have found. The FDA plans to consider Avandia's safety in a mid-July advisory committee meeting, and the agency has noted its concerns about the drug for several years now. It's unclear why FDA officials have not taken action against Avandia already. Internal FDA reports released by the Senate Finance Committee suggest that 500 heart attacks and 300 cases of heart failure could be prevented every month if Avandia patients took Actos instead, and some observers suspect that GlaxoSmithKline had declined to inform the public of these risks, even though the company had known of them for years.

Knowing how many things diabetics have to manage in their lives to stay alive and healthy, it's hard to imagine that a drug manufacturer would choose to put patients' lives at greater risk by withholding or denying information about a drug's safety. But that may be what is happening here -- and if so, it’s illegal as well as bad ethics. Drug companies are legally required to warn consumers of risks that may come with taking their drugs. If they don't, and patients suffer because they took a drug they thought they could trust, drug manufacturers can be held responsible for the physical, emotional and financial harm that results. Diabetes already carries an increased risk of heart and blood vessel disease, so it seems unlikely that patients and their medical caregivers would knowingly choose a drug that seriously increases their risks of heart attack and heart failure.

Continue reading "More Evidence Emerges of Increased Risk of Death and Disability From Avandia" »

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A recent report by KTNV of Las Vegas brings to light some alarming effects of Lupron Depot, a hormone-altering drug known as a GnRH agonist that is widely prescribed for endometriosis and prostate cancer. Leuprolide acetate, sold as Lupron as well as under other brand names, is also used for ovarian stimulation for in-vitro fertilization treatments and a variety of other conditions. Patients have complained of serious negative effects continuing years after they stopped taking Lupron. As a dangerous prescription drugs attorney, I hope that patients are fully informed about Lupron Depot's potentially dangerous effects before they take the drugs, so that they can make an informed decision about it.

Lupron Depot is a long-acting drug that is injected into a patient's muscle tissue once a month, but its negative effects can last longer than patients want. According to the article, 21-year-old Christina Smith of Las Vegas has suffered severe anxiety, muscle pain, migraines, nausea and thyroid damage since her single injection of Lupron three years ago. She says her doctor told her only about "menopausal side effects." Several other women in the article had similar stories, which are backed up by some medical studies. The FDA is currently reviewing the safety of Lupron as a prostate cancer drug, after reports surfaced of a dramatically increased risk of heart problems, diabetes and convulsions. The prescribing information required by the FDA also warns female patients of decreased estrogen, leading to a risk of stopped menstruation, menopause symptoms and permanent loss of bone density. It also is not recommended for pregnant women because of an increased risk of birth defects.

Despite these many risks and negative experiences, manufacturers of leuprolide acetate have continued to market the drug for existing and new uses -- most notably, as a treatment for prostate cancer. But a former U.S. Food and Drug Administration medical officer has said that Lupron's manufacturer, TAP Pharmaceuticals, did not study the drug adequately before or after introducing it to the market, and he alleged that the company hid what it knew about risks of bone density loss, generalized pain, headaches, fluid retention, depression, and immune and nervous system problems, including spinal fracture, convulsions and paralysis. The company paid an $875 million settlement after the Department of Justice charged it with violations of the Prescription Drug Marketing Act and for overcharging and defrauding Medicare and Medicaid. The company had bribed doctors to prescribe the drug. A joint venture of the Japanese company Takeda Pharmaceutical and Abbott Laboratories, TAP was dissolved in 2008 and Lupron is now produced by Abbott. All of this makes me, as a defective prescription medication attorney, concerned about this drug's history.

The combination of TAP's behavior in marketing Lupron and the stories of the women hurt by Lupron should prompt the FDA to take a close look at this drug. Even if the FDA chooses not to ban or restrict the drug, patients who have been harmed by Lupron can make its manufacturer compensate them for the ill effects they have suffered. Drug manufacturers have a legal responsibility to warn the public of any potential negative effects of their products that they know about. If a drug company fails to warn the public and patients get hurt, patients can require the drug manufacturer to pay for the damage caused by its negligence. This can include medical costs, past and future lost wages, lost quality of life, damage to personal relationships, and pain and suffering. It is simply unfair and unethical to withhold information about a dangerous drug in order to protect profits, and the law recognizes that any company that does so should face the consequences of its actions.

Continue reading "Drug Used for Endometriosis and Prostate Cancer Linked With Misery for Patients" »

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The birth control medication Yaz has been linked to an acute medical condition known as a pulmonary embolism. In the shortest possible terms, a pulmonary embolism results when a blood clot forms and travels through the body's blood vessels into one of the lungs. This medical condition is extremely serious and can result in death. The reason Yaz has been linked to this condition is because the hormones in the medicine can cause the blood to thicken and clot more easily.

There are a number of symptoms associated with a pulmonary embolism. If you are taking Yaz and you find yourself experiencing one or more of these symptoms, do not hesitate — go immediately to the doctor.

Symptoms include coughing up sputum (mucus or spit) that has blood in it. It can be reddish or just pink. Pains in the chest, especially those that radiate outward from the chest to a limb, are particularly indicative. Similarly present could be a rapid heartbeat or shortness of breath. Some patients of embolisms have reported an unexplained sense of anxiety, a clamminess or blue color to their skin, swelling limbs, low fever, dizziness and wheezing. Any of these symptoms could be serious, but in conjunction they should be considered an emergency.

The risk is not small. Nearly one in three women who suffer an undiagnosed embolism die from it. Even those who do not die could suffer heart damage, hypertension or even brain damage if the blood flow to the brain is interrupted. These side effects are nearly six times as common in women who take Yaz as in women who take older generation anti-pregnancy drugs, and yet it still remains one of the most popular and widely-prescribed oral contraceptives on the market today.

At the very least, any woman who has experienced this condition while taking the medication would be wise to consult a doctor, and consider all her options.

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Tardive Dyskinesia is very hard to understand for someone who has not experienced the effects, whether directly or indirectly. The disorder is a known, ongoing side effect of the stomach medication Reglan and is characterized by uncontrollable movements in various body parts, ranging from facial muscles to the extremities. It is an intensely uncomfortable and frightening disorder; still, despite the medicine being subject to a black box warning from the FDA, this disorder continues to be waved away under the comforting language of "side effect."

Sometimes the best way to get a perspective on something is to have a firsthand account from a patient affected by the disorder. To that end, consider the case of Joan T. Experiencing symptoms such as stomach pains and diarrhea, she went to her doctor. Believing Joan had Irritable Bowel Syndrome, the doctor prescribed Reglan, which Joan took for just more than a year.

"At first I had no problems with it,” Joan says of the medication. “Then, all of a sudden, I had uncontrollable movements. The doctors thought it was Parkinson's disease."

Parkinson's disease is a very serious illness. There is no known cure, and it can lead to severe complications. It is not by any measure a small consideration. There is a reason Michael J. Fox has poured millions of dollars of research into the illness. Imagine being told out of nowhere that you have this condition.

In addition to this, the involuntary movements interfered with an eye surgery Joan was scheduled to have to correct cataracts. Her head was moving so much they had to physically restrain her for the procedure. Again, these movements are not small, irrelevant things that can be ignored. Tardive Dyskinesia is serious and interferes with people's lives.

Ultimately skeptical, Joan researched the diagnosis of Parkinson's and came across some information about Reglan. Realizing it had a black label warning, she ceased taking the medication and within a short while the tremors and movements stopped entirely.

"You never saw somebody so happy as I was,” she says. “I haven't had problems with the movements since then... I wouldn't recommend Reglan to my worst enemy. It's horrible, having uncontrollable movements. You can try to hide them, but you can't stop them."

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One of the most difficult Effexor-related birth defects is the condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). Described briefly, PPHN results in the infant being unable to breathe properly due to a defect in the way blood interacts with the lungs.

It is not a minor matter, but rather a very serious condition requiring extensive treatments that can be difficult and expensive for a family to bear. The fact that it can result from a medicine intended to treat the mother makes this birth defect heartbreaking.

Treatment of PPHN focuses on getting more oxygen into the infant's blood. There are a number of methods used to do this, each of which create its own unique problems.

The first option is to deliver 100 percent oxygen directly to the child, using either a hood or a mask. This is a temporary solution at best, of course, because the body wasn't designed to process pure oxygen.

Sometimes assisted ventilation is the preferred technique. In this case, a tube is inserted into the child's throat to allow a machine to take over for her breathing. This procedure can be enhanced with the addition of nitric oxide, a gas that helps relax the constricted blood vessels in the lungs, allowing better blood flow and easier breathing.

A treatment of last resort is Extracorporeal Membrane Oxygenation. This treatment is a terrifying one, as it involves putting the child on a lung-bypass machine. In essence, when the child's lungs and heart prove unable to handle the problem, the infant is placed on the machine that draws their blood, cleans and oxygenates it, and then resupplies it back to the child.

Each of these options can be difficult for a parent. Worse, they aren't always guaranteed to work. The idea is to give the infant's body time to adapt to the world and heal while being given assistance, but in some cases the damage is too extensive.

PPHN is a serious condition, and needs to be discussed critically with mothers who are on Effexor while pregnant.

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Recently I wrote about the increased risk of broken bones as a danger associated with popular acid reflux drugs. Now, increased risk of bone fractures has been reported as an effect of drugs meant to prevent bone fractures. Consumer Reports has warned consumers about bisphosphonates, popular osteoporosis drugs such as alendronate (Fosamax and its generic equivalent), ibandronate (Boniva), risedronate (Actonel) and zoledronic acid (Reclast). A Canadian consumer group is planning to launch a class-action lawsuit against Merck, the maker of Fosamax for allegedly concealing the drug's harmful side effects. As a dangerous drugs attorney, I hope that the FDA will take quick action so that people will not be needlessly harmed by these drugs.

Bisphosphonates are marketed to women to prevent bone loss from osteoporosis, but doctors also prescribe them for osteopenia, or "pre-osteoporosis." According to Consumer Reports, the drugs can provide modest help with building bone and preventing fractures in vertebrae bones for patients with osteoporosis, but they aren't clearly effective for osteopenia, a condition that affects more than half of all white, pre-menopausal American women. In fact, studies show that taking bisphosphonates can lead to weak, brittle femur (thigh) bones that break spontaneously -- not from falls, but during low-energy activities such as walking down a flight of stairs. The drugs can also cause osteonecrosis, also known as Fosamax dead-jaw, in which patients suffer jaw damage after dental work.

Carey, Danis & Lowe is currently handling lawsuits related to osteonecrosis caused by bisphosphonates. Patients taking bisphosphonates also face risks including throat or chest pain, difficulty swallowing and heartburn, abnormal heart rhythm (atrial fibrillation); and incapacitating bone, joint and muscle pain. The FDA issued an alert in March about its ongoing safety review of bisphosphonates, saying there was "no clear connection" between the drugs and femur fractures, emphasizing that health care professionals needed to be aware of the risk.

One of the most important problems with bisphosphonates is that their long-term effects are unknown. They are stored in bone for up to 10 years after a patient stops taking the drugs, and during this time, the drugs may actually damage the bone's natural ability to repair and maintain itself. Over the first few years of treatment with bisphosphonates, patients appear to be doing better, but after that, it appears that their condition worsens. In 2008, bisphosphonate sales generated more than $3.5 billion, and that profit alone may be enough to prevent Merck from studying the problem -- to the detriment of thousands of women.

As a dangerous medication lawyer, I'd like to point out that placing profits ahead of people's lives and health is not just unethical, it's illegal. Drug companies have a responsibility to warn consumers of risks that may come with taking their drugs. If they don't, and patients suffer because they took a drug they thought they could trust, drug manufacturers can be held responsible for the resulting physical, emotional and financial harm. Patients with bones weakened because of osteoporosis or osteopenia would not take prescription drugs that they knew would cause them to fracture their thigh bones during normal activities. Patients who do suffer injuries like this can require the drug manufacturers to pay for medical expenses, lost wages, permanent injuries, pain and suffering and other damages related to the injuries that the drugs caused.

Continue reading "Consumer Reports Warns Bone-Strengthening Drugs May Actually Cause Fractures" »

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A few weeks ago, I wrote about the recall of contaminated and overly concentrated children's medications produced by McNeil Pharmaceuticals, a unit of Johnson & Johnson. Since then, more information has become available about the recall, and the FDA and the House Committee on Oversight and Government Reform have launched investigations. Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, said that the FDA is even considering criminal penalties against McNeil. As a defective drug lawyer, I do not believe McNeil has demonstrated an ability or willingness to protect consumers' safety from defective or contaminated medications.

For me, the most troubling aspect of the information that has emerged since the recall began on April 30 was McNeil's apparent sloppiness in both its drug manufacturing and its communications with consumers and the FDA. This applies not just to communications from this year, but going back to at least 2008. First, the April 30 recall turns out to have left out McNeil's 1-mg grape-flavored Zyrtec, which should have been recalled. The company added this product to the recall on May 5, but as a dangerous medication lawyer, I worry that some consumers may have looked at the original recall, seen that this type of Zyrtec was not included and stopped worrying about it. Missing the new recall announcement would have exposed such families to the same serious injuries they were trying to avoid.

Second, McNeil tested some samples of its recalled infants' Tylenol and found that it contained up to 24 percent more of its active ingredient than it was supposed to. The company said that these defective medications did not reach the marketplace. However, it said, "we cannot confirm that all the individual bottles were within specification or that 24 percent would have been the maximum," according to a letter to doctors and poison control officials that was dated May 1. That date was one day after the recall of infants' and children's Benadryl, Motrin, Tylenol and Zyrtec.

Third, and most worrisome, these events look like just the latest episode in a pattern of lax quality control, including McNeil's unnecessary delay in 2008 in reporting problems with Motrin. The company had retailers remove Motrin from store shelves without informing the FDA of the drug's problems. This "paints a picture of a company that is deceptive, dishonest and willing to put the health of children at risk," said Rep. Edolphus Towns (D-N.Y.), chair of the House Committee on Oversight and Government Reform. "What we have uncovered so far is very troubling." McNeil insists that the possibility for harm caused by these defective medications is remote, but the company's sloppy handling of this situation does not inspire a lot of trust in its assessment.

The company may now have to explain itself to the FDA's office of criminal investigation and the Justice Department, since the FDA has referred the case to federal prosecutors. If consumer reports of health problems linked with the defective drugs continue -- and the FDA has already received some -- McNeil may find itself answering in civil court as well. Drug manufacturers have a responsibility to warn the public of potential negative effects their products could cause, and all signs uncovered so far by the FDA and Congress point to McNeil's not having done so. In such cases, consumers who have been harmed by defective medications can sue the drugs' manufacturers for compensation for medical costs, lost past and future wages, lost quality of life, pain and suffering. It's hard enough for parents to see their babies and children sick. When the sickness was caused by medications parents trusted to help their children feel better, the law recognizes that they should not have to bear the financial consequences as well.

Continue reading "FDA and House of Representatives Launch Investigations Into McNeil Recall" »

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As a defective medication lawyer, I noticed a recent spate of reports about alarming risks posed by the third highest-selling class of drugs in the U.S. Six studies have linked the most powerful class of acid reflux drugs, known as proton pump inhibitor antacids, or PPIs, to bone fractures, especially for people who take high doses for a year or more and for people over age 50, because the drugs may disrupt the body's ability to absorb calcium. Another study suggests an increased risk of infection with C. difficile bacteria for patients using this class of drugs.

The FDA advises consumers of "possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers." The warning extends to well-known drugs such as dexlansoprazole (Dexilant), esomeprazole (Nexium), omeprazole (Prilosec and Zegerid), pantoprazole (Prevacid) and rabeprazole (Aciphex), all of which will be required to carry this information on a warning label on both prescription and non-prescription packaging. Patients whose doctors advised them to take PPIs should ask whether they should continue taking them, says the FDA. Patients are advised to use the drugs for only 14 days at a time, and for no more than three 14-day periods over the course of a year. The FDA also suggests that patients and doctors consider lower doses and shorter durations of therapy with PPIs.

PPIs work by stopping stomach acid from being produced, and they are only supposed to be taken for serious conditions like gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the esophagus. But often, people use them for less serious issues like heartburn, which could be treated with less risk of side effects by using antacids like Maalox, Rolaids, or Tums, or hydrogen receptor antagonist drugs like Axid, Pepcid, Tagamet, and Zantac. In fact, doctors write 113.4 million prescriptions for PPIs annually, and three PPIs -- Prevacid, Prilosec, and Zegerid -- are available over the counter.

As a pharmaceutical liability attorney, I wonder why doctors and consumers were in the dark about the risks of using PPIs before the FDA issued its warning. The FDA isn't the only party responsible for warning and protecting the public from risky drugs; the drug manufacturers have a legal responsibility to do this too. Surely the drug manufacturers had access to the six epidemiological studies on which the FDA based its warning. They should have let consumers know of these risks as soon as they knew, as they are legally required to do. Drug manufacturers who fail to warn consumers of risks that they know to be linked to their products violate their legal responsibility, and the law allows consumers harmed by the defective drugs to recover compensation for that harm. That means that a consumer who incurs medical costs, misses work or whose quality of life suffers because of negative effects of a dangerous drug can require the drug manufacturer to pay these costs, which the manufacturer ultimately caused.

Continue reading "FDA Says Popular Acid Reflux Drugs Pose Risks of Fractures and Infection" »

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For those concerned with the potential damage caused by the proliferation of generic versions of dangerous medicines like Levaquin, there is some good news.

A U.S. Federal Court has ruled that India's fifth-largest pharma giant, Lupin, cannot market a generic formulation of Levaquin in the United States — at least not yet. The court upheld a ruling granting Ortho-McNeil's request to extend its patent protection on the medicine. This is, of course, not a final answer, as all protections do expire eventually, but it does mean that for a little longer at least there is a stop on the production of a generic version until December 2010.

Levaquin is an antibiotic used to treat infections that primarily of the prostate and for infections that don't respond well to other medications. However, it also has been linked to tendon deterioration that ultimately results in a tendon rupture, particularly in the Achilles tendons of the ankles. These conditions are often very painful, and can severely inhibit mobility. Some tendon ruptures take up to 12 months to heal when immobilized in a plaster cast.

At most, however, this is a temporary reprieve. Lupin is considered highly likely to file an appeal to a higher U.S. court. There is just too much money involved in Levaquin sales for any other decision; the drug has done $1.4 billion in sales in recent years. Even if the decision is upheld, though, the extension is only until the end of this year. At that point, it is unlikely that any further protections on the patent will be allowed, and companies such as Lupin will be permitted to make their generic offerings.

There are also other companies, such as generic manufacturer Mylan, that are eager to get in on the business. Their appeals have been denied as well, but it is unfortunately only a matter of time.

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The Quincy Patriot-Ledger recently reported that the Food and Drug Administration issued a second warning to Braintree Laboratories about its manufacturing processes. Consumers had submitted 21 complaints to the FDA reporting that they found spiders, insects and insect parts in medications made by the company. Those products include multiple prescription gastrointestinal drugs. As a defective medication lawyer, I wonder what other aspects of the manufacturing process are laxer than they should be. The presence of insect and spider parts in Braintree's medications suggests that the company has not been as conscientious as their moral and legal responsibility requires them to be.

Five different products, all manufactured at the company's Holbrook, Mass., facility, were cited in the consumer complaints. The FDA had investigated the company in December and January and found significant violations of Current Good Manufacturing Practice regulations. Braintree Laboratories said that it would increase its monitoring of pest control, analyze consumer complaints more carefully, and determine the origin of the insects and spiders that consumers found. But the FDAsaid the company still couldn't say whether "facility or raw material quality problems were at the root of these complaints." The FDA is asking the company to submit its plan to find out where the contamination originated and to carefully monitor its raw materials and packaging suppliers. Braintree has 15 working days to either explain to the FDA how it is working to correct the violations or to ask for an extension. If it doesn’t respond, the FDA could seize its products, issue injunctions or withhold future product approval requests.

From my experience as a pharmaceutical liability attorney, I can say that this isn't the first time and it won't be the last time that FDA has had to prod a drug manufacturer to resolve quality issues that affect consumers. Within the last two months, I've written about three other companies whose manufacturing practices have been under FDA's scrutiny, including McNeil Pharmaceuticals, Teva Pharmaceuticals and KV Pharmaceutical. It's disturbing that adhering to FDA manufacturing standards seems to be so difficult for some pharmaceutical companies. I worry that the companies' apparently nonchalant attitude toward product contamination could be a sign that they are equally disinterested in their responsibility to warn consumers of potential negative effects of their products. Drug manufacturers have a legal responsibility to warn consumers and the FDA of any ill effects that could befall someone who uses their products -- e.g., severe side effects from the medication itself, or harm caused by contamination of the medication. When companies wait for the FDA to crack down on them before they clean up their manufacturing processes, they may not be meeting their responsibility to warn the public about the potential harm that their contaminated products could cause. That harm can be serious, up to and including a risk of death in some of the defective medications mentioned above.

Continue reading "FDA Cracks Down on Company Making Medications Contaminated With Insect Parts" »

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Pharmaceutical giant Glaxo Smith Klyne (GSK) has begun a new test study of its controversial antidepressant Paxil using a group of 7-year-old Japanese children as the subjects.

GSK officials confirmed that the test has begun but have not commented on the study. The aim seems to be an attempt at casting doubt on the well-established risk of increased suicidal thoughts when young people take the potent medication.

Part of the controversy surrounding the study concerns its confusing criteria. Officially, the listed information says that this study is an efficacy test — in short, to determine whether Paxil works against a placebo as a control group. However, Paxil already is an approved drug. It has been demonstrated to help people with their depression. This is no longer an issue, so testing it again seems rather odd, unless you consider the company may be looking for some additional good press.

Notably, the study does not include a test against other antidepressant medications as a measure of suicide risk among the selected age group. Given that the drug already has been verified to work, why not test it against other drugs for the most famous problem associated with it? The only allowance the study makes for determining suicide risk is as a secondary aim. In other words, such info is "nice to know," but hardly the goal.

Further, the trial group doesn't seem to be large enough to allow for a truly representative sample. There are only about 130 children listed as participants. With approximately half in the test group and the other half in the control group, this means even small instances of unusual results can change the percentages dramatically. So in short, the study is pursuing something already known, with a sample group nowhere near large enough to provide telling results. Given the very real cases continually levied against GSK, one wonders what the point could be.

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http://www.jefflowepc.com/lawyer-attorney-1176136.html

One of the most frustrating aspects of any major pharmaceutical product liability lawsuit is the sheer slowness of the process. The legal system is designed to move slowly, in order to prevent rushes to judgment that don't properly reflect the facts. On the other hand, people who have been injured by drugs such as Levaquin are suffering now, and dealing with day-to-day pain and the results of ruptured joint structure and mounting expenses while they wait.

Consider that the biggest piece of good news for Levaquin users came late last year, in Illinois.

In September 2009, 15 new lawsuits were filed against a number of companies involved in the manufacture and distribution of Levaquin. These companies include Johnson & Johnson, Ortho McNeill Pharmaceuticals, J & J's Drug Research and Development and distributor Walgreens.

A motion was filed around the same time seeking to have all the suits brought together as a mass tort matter. There is a lot of power in a mass tort suit, forcing the manufacturers to deal with the issue on a larger scale, rather than simply making small, quiet, "go away" settlements and continuing to push their product.

The evidence against Levaquin remains compelling, as it has over the entire life of the drug as a product. Even as far back as 2001, the FDA demanded the medicine carry warnings explaining the risk to tendons and muscle structures. By 2009, the warnings had increased to the FDA's most serious black-box rating, reserved for some of the most potentially harmful medicines FDA still permits to be sold.

Despite this, the manufacturers downplayed the risk of tendon injury, claiming the drug has an excellent safety rating. Hopefully the move to consolidate these actions into a single, major class action suit will force more information into the light, and result in some of the injured patients getting their costs recouped.

source: http://www.articlesbase.com/law-articles/fifteen-additional-levaquin-lawsuits-filed-in-illinois-1264133.html

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As a defective medication lawyer, I have closely watched the continuing reports of problems with drugs manufactured by McNeil Pharmaceuticals. In January, I wrote about the unsettling recall of products made by McNeil Pharmaceuticals, a unit of Johnson & Johnson. That recall involved over-the-counter medications that many of us know well, such as Tylenol, Rolaids, Motrin and St. Joseph Aspirin. Now, the FDA has issued a new recall for commonly used infants' and children's medications that McNeil produces, such as Tylenol, Motrin, Zyrtec and Benadryl.

Initially, the FDA said that the products involved in the current recall could have stronger concentrations than they were supposed to, or they could contain inappropriate inactive ingredients or tiny particles. Just a few days later, we began to see more damning reports, alleging quality and security lapses at McNeil’s Fort Washington, PA, manufacturing plant. A routine FDA inspection of the plant found that raw materials for the infants' and children's medications were contaminated with Burkholderia cepacia bacteria, which is often resistant to common antibiotics. The Center for Disease Control says that the bacteria can be harmful to people with weakened immune systems or chronic lung disease. The FDA was concerned that the contaminated materials could have been used in the products that were recalled, although McNeil says that its tests of those products did not show contamination. The FDA and McNeil both say that the chance of harm from using these products is remote, but they advise customers to stop using the recalled drugs immediately.

Unfortunately, McNeil has not given consumers a lot of reasons to trust its word. The earlier McNeil recall involved medications that had a "musty" smell and that gave consumers stomach pain, nausea, vomiting and diarrhea. It was suspected that the drugs were tainted with 2,4,6-tribromoanisole (TBA), a flame retardant and pesticide used in shipping pallets. The most disturbing part was that McNeil waited at least a year, rather than the legally required three days, after receiving complaints about the medicines before it fulfilled its duty to report the problem to the FDA. In the current case, McNeil appears to be equally unable or unwilling to meet its reporting duties; the FDA has faulted it for failing to report the contamination or recall lots of tainted medicines. And infants and children have less-developed immune systems than adults, so contaminated drugs could put them at serious risk of illness. We still don't know what those "tiny particles" are that McNeil initially cited as the reason for the recall, but there have been over 40 consumer reports to the FDA about dark flecks in the medications.

Now, the House Committee on Oversight and Government Reform plans to hold hearings to investigate McNeil and the FDA. As a pharmaceutical liability attorney, I would recommend that consumers who have been harmed by these contaminated drugs ask questions too, including ones about their legal rights in situations like this. Drug manufacturers have a legal duty to warn consumers and the FDA about risks that their products might pose, such as the risk of bacterial contamination that could cause infection. If McNeil knew about problems and kept them quiet, and consumers took their contaminated medications and became sick, those consumers could sue McNeil to recover all of the costs their illnesses.

Continue reading "FDA and Congress Investigate Contamination and Other Problems at Johnson & Johnson " »

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In recent news, there has been a trend for doctors in neonatal units across the United States to prescribe metoclopramide — brand name Reglan — to treat premature infants for gastrointestinal disorders. This has lead to serious concerns from consumer safety groups. Specifically of concern is the fact that Reglan has never been approved for use in infants.

Reglan was approved for very short term uses by the FDA, with terms limited to no more than three months. It was approved in 1979 for the treatment of gastric disorders. However, the FDA issued a black box warning in 2009, stating that Reglan and its generic forms had been linked to tardive dyskinesia (TD), a disorder that involves involuntary movements, especially of the lower face. A black box warning is the strongest sanction the FDA can impose on a medication. Further studies have showed Reglan is the leading cause of TD among patients who have the disorder in the USA.

Prescription of metoclopramine in neonatal units began approximately 10 years ago, when the only other medicine available was pulled for safety reasons. Those most at risk of developing TD are the elderly and women, but there are concerns about Reglan's effect on infants. There has never been a major study done on Reglan's impact on children, which makes researchers nervous.

According to one attorney, "many doctors and patients are still not aware of the significant risks associated with its use. Because Reglan has been on the market for over 30 years, many physicians assume the drug is safe and prescribe it for various off-label uses. Perhaps the most troubling of these is its use to treat premature babies whose bodies are already extremely frail."

An off-label use is any use of a drug outside its primary function, such as the use of Tramadol to treat restless leg syndrome instead of as a painkiller.

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The U.S. Food and Drug Administration has issued a warning to Teva Pharmaceutical Industries Ltd.'s Parenteral Medicines unit about manufacturing problems that contaminated an anesthetic. As a dangerous drugs attorney, I am dismayed to read that another drug manufacturer has been less than scrupulous with their manufacturing processes. Last month, I wrote about the legal and financial troubles at Ethex Corp., whose parent company is KV Pharmaceuticals here in St. Louis, arising from manufacturing problems that the company admitted that it tried to cover up. Parenteral Medicines would be wise to correct the problems that the FDA points out right away, for its own sake as well as the sake of patients.

Teva Pharmaceutical is an Israeli generic drug manufacturer with a manufacturing facility in Irvine, Calif. In December, the FDA had warned Teva that it needed to correct a problem with vials of propofol injectable emulsion, a general anesthesia drug that it produced. The drug was contaminated with bacterial endotoxin. Endotoxin contamination in pharmaceuticals can be extremely dangerous to patients, as it can lead to fever, lowered blood pressure, and septic shock, a serious medical condition with an approximately 50% mortality rate. Patients who undergo general anesthesia do so for medical procedures like surgery, which already exposes them to risks of complication and infection, so it is vital that they not be exposed to additional unnecessary risks from contaminated pharmaceuticals. In late April, the FDA rebuked Teva for allegedly releasing the contaminated lot of anesthesia and failing to correct the problem. The lot of contaminated propofol was recalled, but the FDA found more problems with Teva's manufacturing practices. It said Teva hadn’t done microbiological testing of rugs or raw materials, and had insufficient cleaning and sanitizing practices.

I have seen enough cases in my work as a drug defect lawyer to believe that making money and saving time are often higher priorities for companies than making sure drugs are safe. The Ethex Corp. case that I wrote about in April was an extreme case, but other drug manufacturers have also faced FDA warnings -- as well as lawsuits from patients who were harmed by defective drugs. Drug companies do not answer only to the FDA; they also are legally responsible to the people who use their drugs expecting that they will help them, not make them sicker or kill them. Patients who have been hurt by medications that manufacturers falsely represented as safe can make the drug manufacturers bear the costs of the harm they caused. Drug makers have a legal responsibility to warn the public and the FDA if their drugs carry risks, and if they do not do so, the law holds them accountable by allowing those harmed to sue.

Continue reading "FDA Rebukes Teva Pharmaceutical for Lax Manufacturing Practices" »

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In February, I wrote about the Senate's report on their investigation of the diabetes drug Avandia (rosiglitazone) and allegedly unethical behavior by the drug's manufacturer, GlaxoSmithKline. As a dangerous prescription drug lawyer, I keep a close watch when drug manufacturers face allegations of unethical behavior, as does GlaxoSmithKline, the maker of Avandia. Now, a Reuters report reveals that the FDA is considering ending a study of Avandia's safety earlier than planned because subjecting study participants to this drug's substantial risk of causing heart attack could be unethical.

A 2007 study by Dr. Steven Nissen of the Cleveland Clinic, published in the New England Journal of Medicine, showed that taking Avandia increased a patient's heart attack risk by 64%. This is a frightening risk for Type II diabetes patients already at high risk for heart attack. University of Washington researcher Bruce M. Psaty, MD, PhD, said, "There is little evidence for using this drug…. The purpose of reducing blood sugar is to prevent cardiovascular events. Now the possibility of cardiovascular benefit associated with Avandia appears remote -- indeed, it appears linked to harm." Avandia already carries a black box warning, the strongest kind of warning from the FDA, about patients' increased risk of heart failure. Two FDA drug safety reviewers recommended pulling the drug from the U.S. market in 2008, and in late March 2010, Saudi Arabia's Food and Drug Authority suspended Avandia for six months.

Meanwhile, GlaxoSmithKline maintains that the evidence does not establish that Avandia increases the risk of heart attack, citing its own long-term study, which of course may not be completely objective. The February Senate report alleged that GlaxoSmithKline also tried to quash information damaging to Avandia by intimidating doctors and downplaying evidence of its dangers. Yet the Senate investigation found that privately, GlaxoSmithKline's own scientists acknowledged that Dr. Nissen's study was sound. As a defective prescription drug attorney, I think it's important that patients be made aware of scientists' and regulators' concerns about Avandia.

By refusing to acknowledge the concerns of the FDA and the Senate, GlaxoSmithKline may be trying to protect its sales of Avandia, which reached $2.8 billion in 2006. But GlaxoSmithKline may pay a big price for doing so. Drug manufacturers can be held legally responsible for the harmful effects of their drugs if they fail to warn the public and government regulators about them. The FDA's decision to consider ending the current Avandia study because of the heart attack risk, along with the Saudia Arabian FDA's suspension of Avandia, suggests that everyone is convinced of Avandia's risks -- but GlaxoSmithKline simply won't acknowledge them until it's forced to. This is a dangerous game to play with patients' health and lives.

Continue reading "Avandia Study May End Early Due to High Risk of Patient Heart Attack" »

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According to pharmaceutical industry journal PharmaLive, the U.S. Food and Drug Administration has rebuked GlaxoSmithKline for false advertising about its chronic lymphocytic leukemia (CLL) drug Arzerra (ofatumumab). In a letter to the company, the FDA says that an advertisement for Arzerra in the Journal of Clinical Oncology fails to mention any of the risks associated with the drug or the limitations on the drug's use. Because of these omissions, the FDA says that the ad implies that Arzerra is safer and more effective than evidence says it is. As a dangerous drugs attorney, I took note of this article because numerous drug companies have been discovered making similar intentional violations, exposing millions of patients to serious risks.

The FDA also upbraided GlaxoSmithKline for failing to submit its Journal of Clinical Oncology ad for the FDA’s review before publication. Because Arzerra was within 120 days of being approved by the FDA for marketing, its promotional materials were supposed to be vetted by the FDA. GlaxoSmithKline had framed the advertisement as a “disease awareness” ad, which purports to inform people about a disease without mentioning a particular drug, so no disclosure of drug side effects would have been required. But the FDA said that the ad's allusions to Arzerra were transparent, and that the ad should have described the adverse reactions to Arzerra that patients could suffer. For example, Arzerra can increase the risk of an often fatal viral infection of the brain, progressive multifocal leukoencephalopathy, which resembles a speeded-up version of multiple sclerosis. Arzerra can also be harmful to patients who have a history of hepatitis.

Drug manufacturers have a legal responsibility to warn doctors and patients of the risks associated with their drugs. As a defective prescription drug attorney, I am glad that the FDA is taking GlaxoSmithKline to task for trying to sidestep its responsibility to inform the public of all relevant safety information about Arzerra. A number of drug manufacturers have been held liable in lawsuits over false advertising of their drugs' effectiveness and safety. Patients with serious illnesses like CLL have enough to worry about without also having to research faulty claims about their medications, or worry about undisclosed safety information. Unfortunately, as the FDA's letter to GlaxoSmithKline shows, drug manufacturers often place their own financial interests ahead of patients' safety.

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Patients being treated for epilepsy, depression, migraine, chronic pain, bipolar disorder, and other conditions may need to be vigilant about suicide-related side effects of their treatment. A recent report on CNN.com details the results of a study just published in the Journal of the American Medical Association (JAMA). It found that taking antiseizure drugs to treat epilepsy and other conditions roughly doubles the risk of suicidal thoughts and suicide attempts, compared with other drugs in the same class. The medications in question are the antiseizure and nerve pain relief drug gabapentin (Neurontin), the antiseizure and bipolar disorder drug lamotrigine (Lamictal), and the antiseizure drugs oxcarbazepine (Trileptal), tiagabine (Gabitril), and the seizure, bipolar disorder, and migraine treatment valproate (Depakote). I see a lot of people who have experienced unexpected negative effects from prescription drugs in my work as a defective prescription drug attorney, and I am glad that news outlets like CNN are making the public aware of these dangers.

In 2008, the U.S Food and Drug found that people who took any of eleven anticonvulsants, as these drugs are called, approximately doubled the risk of suicidal thoughts and suicide attempts. The risk is less than half of one percent -- about one in 230 patients will have suicidal behavior or thoughts. Experts say patients need to be aware of this risk, so that they'll be more likely to notice if they are that one in 230. The FDA required these drugs to carry a warning label about this risk, but did not require a “black box” warning, the most serious kind of warning.

The new study published in JAMA looked at people taking thirteen anticonvulsants over five years and tracked suicide attempts, suicides and violent deaths. It found that five of the drugs increased the risk of suicidal behavior compared with topiramate (Topamax), a widely prescribed and versatile drug in the same class. Aware that many of the anticonvulsants they looked at were used to treat mental illnesses, the authors of the study accounted for the increased risk of suicide because of mental illness as they analyzed the data. They still found that "the risk was derived from the specific drug that the patient was taking and not their underlying conditions," said Dr. Elisabetta Patorno of the Brigham and Women's Hospital in Boston, the lead author of the study. Dr. Andres Kanner of Rush Medical College in Chicago, who did not work on the study, said that patients taking anticonvulsants should tell their doctors if they or a family member have a history of mental illness. Patients should not stop taking the drugs without discussing the issue with their doctors, and they should tell their doctors if they feel depressed or have thoughts of suicide.

As a dangerous prescription drug lawyer, I am glad that patients are gaining access to better information about the drugs that they take, but I am concerned that this information is not coming from the drug manufacturers. The risk of suicide is a well known side effect of certain antidepressants, and it’s not unlikely that the manufacturers could have been aware of it before the JAMA study came out. In fact, the drugmaker Pfizer just settled a wrongful death lawsuit with the widow of a man who committed suicide while taking Neurontin. Pfizer still faces many similar lawsuits and also pleaded guilty to criminal charges in 2004 and agreed to pay $430 million because of how it promoted Neurontin. Neurontin had been one of the company's best selling drugs before it lost patent protection and generic versions became available. These circumstances suggest that some drug manufacturers might have worried that warning people about the increased risk of suicide would harm their profits.

Continue reading "Study Links Epilepsy and Depression Drugs to Suicidal Thoughts and Attempts" »

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As a dangerous prescription drug attorney, I was interested in this story about a St. Louis drug manufacturer's guilty plea to two felony counts of criminal fraud. Ethex Corp, a wholly owned subsidiary of KV Pharmaceutical, admitted that it had failed to report to the FDA that it had been producing generic prescription medications that contained up to double the dose they should have had. Company leaders admit that they knew about the problem in the spring of 2008, but kept quiet about most of the drugs until an FDA order shut down production in January of 2009. They blame the problem on bad managers who have since been pushed out. Despite 15 months of no production or sales, KV faces at least 30 lawsuits, 15 of which are wrongful death claims.

In May 2008, pharmacists in California and Canada discovered that morphine sulfate tablets produced by Ethex were much larger than they should have been. Overdoses of morphine, an opiate, can cause a person to stop breathing and go into a coma. KV Pharmaceuticals recalled the defective morphine tablets the next month. However, they decided not to do anything in response to reports of similarly oversized tablets of other drugs like propafenone, a medication for irregular heartbeat, and dextroamphetamine sulfate, a component of Adderall, the attention-deficit disorder drug. Propafenone overdose can lead to coma and seizures, and dextroamphetamine sulfate overdose can, in extreme cases, lead to amphetamine psychosis, in which a person experiences hallucinations and goes for long periods of time without sleep.

Assistant U.S. Attorney Andrew Lay wrote in court papers that a KV executive knew about these problems and decided that since there was low probability that more oversize tablets would be found, the company should do nothing, even though other employees objected to this approach. This executive told employees to avoid discussing the problem in writing as much as possible, and to limit the number of people who would find out about it. In other words, the executive orchestrated a cover-up. KV employees said that they were encouraged regularly to falsify records so that the FDA would think that KV was in compliance with FDA standards on chemical tests and cleanliness of the equipment used to produce the drugs.

In the end, the company's emphasis on production over safety has already severely affected its bottom line -- industry watchers say KV could be bankrupt within the year. It is no surprise to me, as a drug defect attorney, KV is facing so many lawsuits over defects in its drugs. Over 200 more pending claims have not yet made it to court, and 26 of those involve a patient's death. CVS Pharmacies is also suing KV for $100 million for allegedly breaking a supply contract.

Continue reading "Drug Manufacturer Admits It Ignored Duty to Warn FDA of Its Defective Products" »

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The FDA issued a warning to patients that Zocor (simvastatin) can cause muscle injury, or myopathy, to those who take the drug at its highest approved dose. Zocor, a statin drug, is used to control cholesterol levels and to prevent cardiovascular disease. Simvastatin is sold as on its own as Zocor or in generic form, as well as in combination with ezetimibe as Vytorin and with niacin as Simcor. Since Zocor has been a popular drug for over two decades, as a pharmaceutical liability attorney, many people could have experienced the more severe forms of myopathy that the FDA is warning us about.

The FDA's statement pointed out that "Although muscle injury ... is a known side effect with all statins, the warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug." Rhabdomyolysis, the most serious kind of myopathy, involves the breakdown of muscle fibers and release of the protein pigment myoglobin into the bloodstream. It often can result in severe kidney damage, kidney failure, and even death. People suffering from this condition can also experience weakness, fatigue, joint pain, seizures, and weight gain. The FDA advises patients not to stop taking Zocor unless their doctors advise them to, and to talk to their doctors if they have questions.

The data that the FDA considered in issuing this warning also calls into question whether Zocor is more likely than other statins to cause muscle injury. Simvastatin has been on the market since the late 1980s, so it is somewhat surprising that it has taken this long for the FDA to recognize the seriousness of the problems Zocor can cause. In fact, the statin Baycol (cerivastatin) was withdrawn from the market in 2001 precisely because it was found to carry an extremely high risk of rhabdomylosis -- up to 80% higher than other statins. Before its U.S. patent expired in 2006, Zocor was Merck's best selling drug, and the second-best selling cholesterol-lowering drug in the world, netting $4.3 billion in sales in 2005. Since then, Merck has tried hard to avoid losing its share of the Zocor market to generics, lowering the price for brand-name Zocor so that it could compete with the generics. As a drug defect lawyer, I wonder if Merck knew about these problems, but didn't want to jeopardize the huge profits Zocor brought in while it was still under patent. After all, it was the FDA that brought the muscle injury risk to the public's attention -- not Merck.

The FDA says that rhabdomyolysis is a rare adverse effect of Zocor. But those patients who do develop the condition will have to contend with not just their original heart and cholesterol problems, but painful and debilitating muscle and kidney problems as well. In extreme cases, kidney failure from rhabdomyolysis could mean death or a need for a kidney transplant. If Merck was aware before now of the problems with higher dosages of Zocor, but neglected to warn the FDA and the public, patients who have been adversely affected by the drug could hold Merck legally responsible. Drug manufacturers have a responsibility to warn doctors and patients of adverse effects that their drugs cause. When they fail to do so, the law makes them responsible for all of the injuries to patients that result. This includes all of patients’ medical costs as well as the personal cost of a new and permanent disability.

Continue reading "FDA Warns Patients That Cholesterol Drug Zocor Can Cause Muscle Damage" »

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According to the popular health information Web site WebMD, the U.S. Food and Drug Administration has ordered a “black box" warning for Plavix (clopidogrel), a blood thinning drug. That is the strictest safety warning the FDA issues. The move comes after research showed that the drug’s effectiveness at normal doses is substantially reduced in people who carry certain genes. This is bad news, because Plavix is prescribed to help prevent heart attacks, strokes, blood clots in patients with stents and other serious cardiovascular problems. Plavix is the second-best-selling drug in the world, so the number of patients affected could be very large. Patients who fall into this genetic group without realizing it are at risk for any or all of these problems, and as a pharmaceutical liability attorney, I hope that Plavix-taking patients talk to their doctors about this as soon as possible.

The FDA said 2% to 14% of patients have a gene that makes it harder for their livers to metabolize the drug, which means less of it gets into their bloodstreams. That was true for about 2% of white patients, 4% of black patients, and 14% of Chinese patients, the agency said. Doctors can find out whether a patient is a poor metabolizer of Plavix by using a genetic test. This test can also show if a patient will be an "intermediate responder" or a "hyper-responder" to the drug. Unfortunately, the test costs about $500, and the amount of time it takes to get the results varies from a few hours to several weeks. For patients who are at imminent risk of having a second heart attack or stroke, waiting for several weeks to find out whether Plavix will be able to help them is "not a good idea," said the director of FDA's office of medical policy, Dr. Robert Temple. PBS' NewsHour blog The Rundown says that doctors do not typically order the genetic test before prescribing Plavix.

This is not the first time Plavix's effectiveness has come under scrutiny. In November of 2009, the Wall Street Journal reported on studies that showed Plavix's effectiveness was reduced when it was taken with some heartburn medicines. Use of heartburn medicines with Plavix is common because stomach bleeding and ulcers are common side effects of the drug. Ironically, the study found that taking a heartburn drug to treat Plavix's side effects causes it to stop working properly and raises patients' risk of heart attack and stroke by 50%. Earlier, in May of 2009, the FDA had warned patients and doctors about Plavix's poor metabolizer problem by changing information on the drug's label. The black box warning comes after the agency reviewed more data. The label asks doctors to "use the best information possible to treat their patients" and consider alternative treatments. Patients are cautioned not to stop the drug without talking to their doctors first.

As a dangerous prescription drug attorney, I am concerned that it took so long for this information to result in a serious warning. Plavix has been on the market for over a decade, and is a best-selling drug. With so many users, scientists have had a lot of opportunities to spot problems, so it would be interesting to know how much Bristol-Myers Squibb and Sanofi-Aventis, the companies that market Plavix, knew about these problems before the label changes. Would Plavix have become the second-best-selling drug in the world if patients and doctors knew they needed a $500 genetic test to find out whether it’s effective? How many people have had heart attacks or strokes while taking Plavix, thinking that they were taking the best medication available for their condition? If Bristol-Myers Squibb and Sanofi-Aventis knew of these problems and did not warn doctors and patients appropriately, they could be held responsible for harm suffered by patients who took their drug.

Continue reading "FDA Adds Black Box Warning About Effectiveness to Label of Blood Thinner Plavix" »

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As a dangerous prescription drug attorney,I have paid close attention to the diabetes drug Avandia (rosiglitazone) ever since a 2007 study showed it increased risk of heart attacks substantially. That study, authored by Dr. Steven Nissen of the Cleveland Clinic and published in the New England Journal of Medicine, found that taking Avandia increased the risk of cardiac death by 64%. The study was particularly alarming because Avandia is taken by Type II diabetics, whose disease already puts them at high risk for heart problems. Among other things, this spurred a black box warning about heart failure and a Congressional investigation into allegations of unethical behavior by manufacturer GlaxoSmithKline. On Feb. 20, the Senate Finance Committee released the results of its investigation, and according to a Feb. 22 article from USA Today, the results are damning.

Most importantly, the Finance Committee found that GSK knew Avandia carried heart risks for several years before Nissen’s study. It accused GSK of trying to intimidate doctors who came to negative conclusions about the drug and minimizing or misrepresenting scientific evidence. It also said from U.S. Food and Drug Administration employees want the drug taken off the market. The FDA released a statement Monday telling patients not to quit taking Avandia without talking to their doctors, and announcing a panel meeting in July to discuss the results of a long-term, GSK-funded study of the cardiovascular risks of Avandia in Type II diabetics. The results are already in, but the agency said it needed more time to analyze them. An earlier panel voted 20-3 that Avandia does raise risk of heart attacks, but voted 22-1 to recommend keeping it on the market. It currently has sales of $1.19 billion in the United States.

Also on Feb. 22, the New York Times ran a related piece about a meeting between Nissen and GSK, just 11 days before Nissen’s study was published. Nissen legally audiotaped the meeting, concerned about intimidation by the company. He said executives made several false claims, including suggesting they had contradictory information that they could publish jointly with his study. According to the Congressional report, GSK already had the results of Nissen’s study, thanks to a journal reviewer who was also a consultant to the company. But it pretended it did not at the meeting. And even though GSK publicly criticized Nissen’s evidence and methodology, Congress found that GSK’s own scientists said Nissen’s work was sound.

We still don’t have the final results of the RECORD study, and the Times said its interim results were not conclusive. But as a pharmaceutical liability attorney, I don’t believe the public can trust a study funded by GSK. If the claims made by Congress and Nissen are true, GSK has repeatedly attempted to cover up, misrepresent or downplay scientific evidence that Avandia is dangerous, sometimes through intimidation. That behavior casts doubt on any conclusions reached by scientists on GSK’s payroll. Given that patients may risk death or lifelong heart problems from taking Avandia, the risk is just too great. If the existing evidence is not great enough to justify pulling Avandia from the market, as some regulators and safety groups want, the FDA should severely limit its use while it conducts a rigorous independent study.

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As a dangerous drug attorney, I was interested to see a recent study adding information to the debate about antidepressants and breast cancer. A Feb. 9 article from HealthDay reports that researchers have found an increased risk of dying for breast cancer patients taking both the cancer drug tamoxifen and the antidepressant Paxil (paroxetine). The study is important because antidepressants are frequently prescribed to tamoxifen-taking patients to help reduce the menopause-like hot flashes that are a side effect of the drug. It also helps to clarify previous studies that have found mixed and uncertain results when examining the relationship between tamoxifen and antidepressants.

The study, conducted at Sunnybrook Health Sciences Center in Toronto and published in the Feb. 8 issue of the British Medical Journal, looked at the medical records of 2,430 women taking tamoxifen for breast cancer between 1993 and 2005. About thirty percent of the patients were also taking an antidepressant, with Paxil the most common antidepressant. The risk of dying from breast cancer went up significantly for the patients taking Paxil, the study found, and the risk was greater the longer patients took both drugs. Paxil, a selective serotonin reuptake inhibitor, inhibits a bodily enzyme needed to process tamoxifen, the researchers said. This was not seen with other SSRIs, like Effexor or Celexa. Lead researcher Dr. David Juurlink suggested that patients and doctors discuss transitioning to an antidepressant other than Paxil, but warned that quitting the SSRI cold turkey can cause withdrawal.

This study interests me as a defective prescription drug lawyer because it may help settle a debate in the medical community. Scientists already knew that SSRIs can interfere with the enzyme described above, but two 2009 studies conflicted about whether this lead to an increased risk of death. This study provides strong evidence that Paxil, at least, may interfere with the effectiveness of the breast cancer drug. And that means that thousands of patients may have been put at an unnecessary risk of dying. It also means that breast cancer patients may have been unnecessarily exposed to the numerous serious side effects of Paxil. Paxil already carries a warning about increased risk of suicidal thoughts and can cause reproductive and sexual problems in both men and women. As the article mentioned, it can also cause severe withdrawal symptoms.

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The psychiatric drug Zyprexa (olanzapine) has been at the center of several controversies interesting to defective drug attorneys like me, due to its illegal off-label marketing and its connection with major metabolic disorders like diabetes. On Jan. 29, the U.S. Food and Drug Administration struck another blow against the drug when it announced it will require more stringent warnings on the label about the risk of weight gain in teenagers. The FDA’s announcement said doctors should carefully consider the increased potential for weight gain and hyperlipidemia among teenagers, as opposed to adults, taking Zyprexa. It said this should lead doctors to consider prescribing other drugs, and reminded them that the drug should be part of a comprehensive treatment plan.

Zyprexa is an atypical antipsychotic approved for use in patients with bipolar disorder or schizophrenia. Research has connected its long-term use among adults to weight gain, high blood sugar, diabetes and pancreatitis. According to a Jan. 29 article on the Los Angeles Times blog Booster Shots, a study published in October showed an even more dramatic weight gain in teenagers taking Zyprexa -- an average of 17 pounds over 12 weeks. The teenaged participants also had more dramatic increases in triglycerides (fats in the blood) and cholesterol levels than adult patients. The FDA cited that study in its letter informing drug maker Eli Lilly about the label order. A year ago, Lilly settled a federal lawsuit claiming it put adults at unnecessary risk of these injuries by illegally marketing Zyprexa for off-label uses like dementia and anxiety. The new FDA letter also mentions Zyprexa’s greater potential for liver damage and sedation in teenagers.

I am pleased that the FDA is taking the risk of metabolic problems from Zyprexa seriously. But as a dangerous prescription medication lawyer, I’m disappointed that the label wasn’t stronger. For one thing, seventeen pounds in 12 weeks is a very dramatic weight gain -- 1.4 pounds a week. By contrast, scientists believe the average, non-dieting American adult gains half a pound to two pounds a year. With Zyprexa use, that weight gain is associated with life-altering or even life-threatening disorders like pancreatitis and diabetes. For another, the FDA’s warning entirely omitted mention of the results showing higher risks of sedation and liver damage in teenagers. Liver damage can cause permanent, lifelong disabilities, and while sedation itself may not be dangerous, it can impair judgment and motor skills, leading to dangerous situations.

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As a dangerous drug attorney, I was interested to note last fall that the FDA was studying reports of increased heart attacks among patients taking diet drug Meridia (sibutramine). On Nov. 20, the FDA announced that an ongoing study showed higher-than-usual rates of heart attacks, strokes, cardiac arrest and death among people with underlying heart conditions who were taking Meridia. The study, conducted by drug maker Abbott Labs, was allowed to continue. On Jan. 21, just two months later, the FDA announced a new label warning that patients with a history of heart problems or high blood pressure should not take Meridia. In the same week, the European Medicines Agency recommended an outright ban, causing Abbott to withdraw it from the European market.

A relative of antidepressants, Meridia works by blocking brain chemicals that influence appetite. According to a Jan. 26 article on Time magazine’s Wellness blog, scientists knew more than a decade ago that it could raise blood pressure, and the American Heart Association issued a warning about it to heart patients. European regulators asked Abbott in 2002 to study the issue. It responded with the long-term SCOUT study, following 10,000 patients with a history of heart disease or diabetes. Over the six years of the study, 11.4% of participants taking sibutramine suffered death, heart attacks or strokes. By contrast, just 10% of the participants using a placebo suffered one of those events. The FDA’s new warning label saying the drug is contraindicated for patients with a history of congestive heart failure, stroke, coronary artery disease, heart arrhythmias, uncontrolled hypertension and peripheral arterial disease.

As a pharmaceutical liability attorney, I applaud the FDA’s action -- but I wonder why it didn’t follow the Europeans’ lead and consider a ban on sibutramine. The human body works the same on both continents; the difference is only how the regulatory agencies chose to respond. The safety advocacy group Public Citizen has long asked the FDA for a ban on Meridia, claiming it has caused at least 80 deaths, including 30 deaths of patients under age 50. The SCOUT study data only adds to the evidence that this drug has serious safety problems. This is particularly true considering that sibutramine’s target market, obese people, is statistically more likely than average to have a heart problem. By continuing to allow sales of sibutramine in the United States, the FDA and Abbott may be exposing patients to deadly and unnecessary risks.

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As a dangerous drug attorney, I have watched the recall of McNeil Pharmaceuticals products with interest. McNeil, a unit of Johnson & Johnson, has recalled multiple over-the-counter pain relievers because of a “musty” smell believed to be caused by a chemical used in shipping pallets, called 2,4,6-tribromoanisole (TBA). Consumers have reported stomach pain, nausea, vomiting and diarrhea after taking the tainted drugs. After finding trace amounts of TBA in Tylenol Arthritis Caplets, McNeil recalled some lots of that drug. It expanded the recall in December to include all lots, and again in early January to include multiple major OTC brands. Perhaps more importantly, the FDA sharply rebuked McNeil in a Jan. 15 warning letter for failing to fully investigate complaints about the odor or notify the FDA, despite receiving the first complaints in early 2008.

Consumers can find a list of the recalled drugs on the FDA’s Web site and learn more at mcneilproductrecall.com.

TBA is a flame retardant and pesticide. It is not well studied, but was not proven to cause harm to humans before this recall. According to a Jan. 15 Associated Press article, 70 consumers have complained to the FDA about the smell or an illness related to a TBA-tainted McNeil product. According to the warning letter, an FDA investigation of McNeil’s Puerto Rico manufacturing facility found that McNeil began receiving complaints over four months in 2008. Nonetheless, McNeil stopped its investigation after tests failed to find microbial contamination. The FDA called this decision, and the failure to look for other causes, premature and unjustified. Further complaints let to tests that fingered TBA, but the FDA said McNeil didn’t test drugs other than specific lots of Tylenol Arthritis Caplets for the chemical. Nor did it submit a report to the FDA within three working days of identifying the problem, as required by law -- instead, it waited at least a year.

The FDA’s letter raises disturbing questions for pharmaceutical liability lawyers like me. The recall currently includes more than 50 million bottles of popular over-the counter products, including Tylenol, Rolaids, Motrin and St. Joseph Aspirin. McNeil’s apparent year-long delay in addressing the problem means millions of consumers were likely exposed to TBA, possibly multiple times. It’s not clear what effect that might have on them, but the gastrointestinal reaction by some consumers, and the fact that it’s poorly studied, suggests that it’s better to stay away. If later investigations show that McNeil failed to take quick action on a serious health threat, the company could face thousands of lawsuits from sickened consumers.

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As a dangerous drug injury attorney, I was disappointed to see two new studies on the use of risky atypical antipsychotic drugs. According to a Jan. 11 article from HealthDay, a new study in the Archives of Internal Medicine found that nursing home patients are more likely to be prescribed an atypical antipsychotic than patients outside of homes. This is despite the fact that prescriptions fell sharply after a 2005 “black box” safety warning from the U.S. Food and Drug Administration, disclosing an increased risk of death in older patients with dementia.

Atypical antipsychotic drugs such as Risperdal and Abilify are used to treat mental illness. They are also widely used off-label to control the behavior of people with dementia, despite the health risks. A series of FDA actions throughout the decade warned patients that atypical antipsychotics increased their risk of strokes; metabolic problems like hyperglycemia and diabetes; and increased mortality among older people with dementia. They also carry a warning about the risk of tardive dyskinesia, involuntary repetitive movements that appear or continue even after the drug is stopped.

The study, from the University of Massachusetts Medical School in Worcester, found that almost a third of all nursing home patients were prescribed atypical antipsychotics for any reason. Of these, the study said, one-third did not have a diagnosis of schizophrenia or dementia. They also found that patients were more likely to be put on antipsychotics if they entered a nursing home where antipsychotics were already heavily used, suggesting that “organizational culture” rather than patient care was driving the decisions.

As a pharmaceutical liability attorney, I’m concerned about the continued use of these medications, particularly in patients with no mental illness or dementia to justify it. As the article notes, no medication is approved for controlling the behavior of people with dementia. One scientist said in the article that antipsychotics are the only drug known to work for this purpose -- but as another one noted, nursing home residents are a vulnerable population. In an institutional setting, without family members watching, it’s all too easy for caregivers confronted with difficult behavior to simply drug patients. But given the risk of death or permanent disability, this is a dangerous and irresponsible use of caregivers’ power over their charges.

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As a defective drug lawyer, I keep a close watch on news related to prescription antidepressants because so many have had safety issues. That’s why I was very interested in Jan. 5 articles from Dow Jones Newswires and Reuters about a new study examining the effectiveness of antidepressants. The study, published in the Journal of the American Medical Association, analyzed the results of six studies comparing prescription antidepressants to placebos. It found that antidepressants make a substantial difference for the most severely depressed. But for mildly to moderately depressed people, the study found, antidepressants had little or no effect compared to a placebo.

A total of 718 patients were in the analysis, conducted by scientists at the University of Pennsylvania. The studied compared both Paxil (paroxetine) and the 1950s-era drug imipramine to placebos over a six-week period. Patients’ depression was measured by a Hamilton score, with the most severely depressed scoring at 24 or higher and the mildly depressed scoring at 18 or below. Among the most severely depressed, those taking genuine antidepressants saw their Hamilton scores drop by 13 points, while patients on placebos saw a drop of 9 points. By contrast, people with Hamilton scores of 23 or below saw an 8-point drop for patients on antidepressants and a 7-point drop for those on placebos. In other words, it concluded that antidepressants work best for the most depressed patients, but aren’t much better than non-pharmaceutical treatment for the mildly depressed.

This is important for two reasons. Robert DeRubeis, a study author and Penn psychologist, told Reuters that most drug approval studies focus on the most severely depressed, even though most depressed Americans have only mild to moderate depression. This suggests that drug approval studies may not serve the majority of the patients. DeRubeis also noted that studies have shown that talk therapy, exercise and even self-help books have shown some effectiveness in fighting depression, without the negative side effects drugs can cause. As a pharmaceutical liability attorney familiar with the dangerous effects of Paxil, I couldn’t agree more. Paxil already carries a black box warning about the risk of suicidal thoughts, and is believed to cause birth defects as well as several other dangerous risks. If it turns out that pharmaceutical companies have exaggerated its effect for most patients, they would have exposed patients to these severe risks in exchange for next to no benefit.

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As a pharmaceutical injury attorney, I already knew that Type II diabetes drug Byetta (exenatide) had serious safety problems. In fact, when it was approved as a stand-alone treatment for diabetes this fall, I wrote about the labeling changes the FDA required as part of that approval, which included stronger warnings on the risk of kidney problems. Just last week, a financial analyst uncovered new information related to that approval that has major implications for Byetta’s safety. According to a Dec. 23 article from Bloomberg News, the FDA required the drug’s manufacturers to conduct more studies to determine the risk of acute pancreatitis, acute kidney failure and thyroid neoplasms.

Byetta is jointly manufactured by Eli Lily & Co. and Amylin Pharmaceuticals. In its Oct. 30 approval letter, the FDA told the manufacturers that it had post-marketing reports of the three serious diseases. They included reports of hemorrhaging or necrotic pancreatitis, both of which can be fatal; acute kidney failure leading to death or kidney transplants; and thyroid neoplasms, which can lead to thyroid cancer. Because this was new safety information not known when Byetta was approved, federal law required new studies to ensure that the drug’s benefits outweighed its risks. According to the letter, some of these studies are already in progress or even completed. But because this requirement was not mentioned in the manufacturers’ approval announcement, the new announcement before Christmas caused a drop in Amylin’s stock prices.

This is disturbing news not just for investors, but also for patients and defective drug lawyers like me. Byetta’s manufacturers almost certainly withheld the information because they didn’t want to hurt the drug’s sales or their stock prices. They may have achieved those goals -- at least until the financial analyst found the publicly available approval letter -- but they have also withheld safety information that can help patients make the best possible decisions about their own treatment. All three of the diseases that triggered the new studies are life-altering and potentially fatal. Acute pancreatitis, a sudden and serious digestive problem, can lead to the pancreatic tissue dying (necrotizing) and bleeding into the abdomen (hemorrhaging), both of which increase the chance of death significantly. Given the risk of death or disability from these diseases, patients and doctors should know about that risk so they can discuss alternatives.

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As a pharmaceutical liability attorney, I was disturbed to read about a new warning of serious side effects for the antidepressant Norpramin (desipramine hydrochloride). According to a Dec. 2 article from Medscape, the FDA and drug manufacturer Sanofi-Aventis have made significant changes to the warning label on Norpramin to reflect a risk of serious heart problems in patients taking the drug. The label now advises health care professionals to use extreme caution when prescribing Norpramin to patients with a family history of sudden cardiac death, arrhythmia (a heartbeat that’s too slow, too fast or not regular) or cardiac conduction disturbances.

Norpramin (sold as Pertofrane outside the U.S.) is primarily used for treating depression, but also in patients with nerve pain, cocaine withdrawal or attention deficit disorder. It is part of the tricyclic class of antidepressants, which were widely used until the introduction of the newer selective serotonin reuptake inhibitors. Along with the warning on heart problems, the FDA letter announcing the labeling changes (PDF) added a general warning to health care professionals that some patients who suffered death and cardiac arrhythmia have suffered seizures beforehand. Because an overdose of Norpramin has shown a higher risk of death than overdoses of other tricyclic antidepressants, the label also included specific instructions for doctors to treat overdose patients. Finally, the label changes deleted previous treatment advice that narrowed doctors’ options for treating an overdose.

As a dangerous drug lawyer, I hope doctors and patients take quick action on this warning. Prior to this announcement, the primary known safety problem with Norpramin (and other tricyclic antidepressants) was a heightened risk of depression, particularly in children. With this announcement, it appears that adults with a family or personal history of heart problems, a very different group, may have been lulled into a false sense of security. The FDA letter did not say how it and Sanofi-Aventis discovered the elevated cardiac risks, but as a rule, major safety changes like this are announced only after multiple reports of patient safety problems or new scientific studies. That means the chances are good that thousands of patients were unknowingly exposed to the cardiac risks of Norpramin. And because overdose of tricyclic drugs is a significant drug poisoning problem -- British and Australian studies found that 8 to 12 percent of drug overdose deaths were from tricyclic antidepressants -- the risk of death may be greater still.

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The Lowe Law Firm filed a lawsuit in November alleging that a client developed a life-threatening disease after being given certain drugs in support of an MRI test. So our pharmaceutical liability attorneys were extremely pleased to see a report just a few days later that the FDA has also been investigating this class of drugs -- and that it found a greater risk with one drug our client was given. According to a Nov. 25 article from Reuters, an FDA memo released the day before Thanksgiving showed that MRI contrast agents made by GE Healthcare, Bayer AG and Covidien raise patients’ risk, even compared to other manufacturers’ versions of similar MRI imaging contrast agents made with gadolinium. The agents are injected into patients undergoing MRIs to help doctors see the resulting images better.

The entire class of imaging contrast agents already carries a black box warning disclosing that they increase risk of nephrogenic systemic fibrosis in patients with kidney problems. NSF is a disease that builds up collagen in the skin, eyes, joints and internal organs. The hardening of the skin and contracture of the joints can leave patients disabled by limited movement, physically scarred and with chronic pain. In its memo, the FDA announced that the greatest number of NSF cases were linked to use of GE Healthcare’s Omniscan -- the first contrast agent given to our own client. The FDA also found a greater risk for Bayer AG’s Magnevist and Covidien’s Optimark. Its review recommended labels on those products warning of the greater risk. At an already-scheduled meeting Dec. 8, the agency plans to ask an expert panel for advice.

As a dangerous drug lawyer, I am extremely pleased that the FDA is taking aggressive steps to limit kidney patients’ exposure to this toxic substance. In this, our government is just a short step behind the European Medicines Agency, which on Nov. 20 classified gadolinium-containing agents into low-, medium- and high-risk agents for kidney patients based on their chemical content. All three of the agents the FDA found associated with higher numbers of NSF cases are on EMEA’s high-risk list. With so much evidence against these higher-risk agents, I hope the FDA takes steps to end their use entirely, or at least require very strong warnings about the risk to people who have -- or may have -- kidney problems. Otherwise, far too many people may suffer preventable but life-altering problems similar to our client’s, which include permanent disability, disfigurement and many thousands of dollars in medical bills.

Continue reading "FDA Finds Greater Risk of Fatal Disorder From Certain MRI Drugs With Gadolinium" »

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As a dangerous medication lawyer, I was gratified to read that a woman from Peoria, Ill. was awarded $6.3 million in damages after a finding that her breast cancer was caused by hormone replacement therapies. Reuters reported Nov. 20 on the largest Prempro award to date, handed down to Donna Kendall of Decatur, Ill. Kendall, 66, sued pharmaceutical company Pfizer after spending 11 years taking the hormone replacement drugs Prempro and Provera, products of Pfizer corporate units. She was diagnosed with breast cancer in 2002, the same year that new research showed dramatic increases in breast cancer and cardiovascular problems for postmenopausal women taking the drugs. In her lawsuit, Kendall said Pfizer failed to adequately warn her and other patients of these risks. The jury indicated that it planned to award punitive damages as well, suggesting that it felt there was evidence of serious wrongdoing.

Prempro was once widely recommended for post-menopausal women, to treat symptoms of life after menopause. However, that changed after the 2002 study from the Women’s Health Initiative at the National Institutes of Health. That long-term study showed a substantially increased risk of breast cancer, heart attacks and strokes among users of Prempro, Provera and Premarin. In fact, that study was ended early because of concerns for the participants’ health. Later studies confirmed the link and suggested that Prempro may also raise women’s risk of blood clots and dementia. Perhaps most damningly of all, later evidence showed that Wyeth, a unit of Pfizer, paid medical ghostwriters to plant articles in medical journals under doctors’ names. At least some of the articles denied the breast cancer link altogether, triggering multiple lawsuits and a Congressional investigation.

As a pharmaceutical liability attorney, I am pleased to see the justice system doing its job with these drugs. By now, most observers agree that the FDA approval process, while important, is not enough to ensure that drugs are safe. Too many drugs have slipped through the cracks in recent years, including drugs that have since been linked to life-threatening diseases. In a few cases, pharmaceutical companies have also been caught misleading the public, as with Prempro, using deceptive advertising, biased medical studies and unethical corporate policies. In addition to causing unnecessary deaths and lowered quality of life to patients and their families, these drugs can also trigger six or even seven figures in bills for medical care that patients would never have otherwise needed. As the FDA itself once acknowledged, lawsuits like this one help incentivize drug companies to stay honest by generating severe financial costs and negative publicity when the issues are publicly and fully aired.

Continue reading "Jury in Prempro Trial Awards Illinois Woman $6.3 Million for Link to Breast Cancer" »

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As a St. Louis defective drug attorney, I was disturbed to read about a new Food and Drug Administration warning of potential irreversible cartilage damage from certain anesthetics and medical devices. According to a Nov. 17 article from the Wall Street Journal, the FDA has called for stronger warnings on the labels of pain pumps and certain anesthetics after 35 reports that they caused permanent cartilage damage (chondrolysis) in patients who received continuous infusions after surgery. In more than half the cases, patients needed additional surgery, including joint replacements for otherwise healthy young adults. The FDA required pain pump and anesthetic makers to update their labels within 30 days to include warnings about the destruction of cartilage.

The drugs in the FDA’s announcement include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine, all widely used local anesthetics. The FDA’s announcement noted that these drugs have been used safely for years or decades, but in smaller, short-term doses. They are not approved for continuous use or use in pain pumps, which deliver constant flows of medication over two or three days. In fact, the pain pumps themselves are not approved for use in joint (intra-articular) areas, the uses that generated the cartilage damage reports. Dr. Constance Chu, a cartilage restoration specialist the University of Pittsburgh, told the Wall Street Journal that local anesthetics are toxic to tissues at high doses and not intended for continuous use. The Canadian version of the FDA issued a warning about cartilage damage in January, following studies and reports on the issue.

Almost all (97%) of the surgeries the FDA reviewed were shoulder joint surgeries. Patients reported stiffness, loss of motion and joint pain as soon as the second month after their surgeries. About half needed additional surgeries to relieve the pain and symptoms, including joint replacements (arthroscopy). Cartilage damage and loss is not life-threatening, but it has an immense effect on the patient’s quality of life. Without cartilage, the bones in joints grind against one another, causing pain, swelling, loss of mobility and thus severe restrictions on the patient’s movement. Osteoarthritis, a common complaint among older Americans, is a form of cartilage loss with similar symptoms. A newer treatment called articular cartilage repair can mend some of the damage to cartilage, but this cannot restore cartilage. Expensive joint replacement surgery may be necessary to restore patients’ normal movements.

The Wall Street Journal noted that pain pump manufacturers are already facing hundreds of lawsuits around the United States over post-operative cartilage damage. As a southern Illinois pharmaceutical liability attorney, I expect the FDA’s warning to add to that number. If the FDA is correct, both the pain pumps and the anesthetics are apparently being widely used for off-label, unintended purposes. This report makes it explicit that the FDA does not approve of those uses, and is even taking steps to warn doctors and patients against them. In fact, medical studies turned up these problems as early as 2006, but manufacturers failed to warn patients about them -- and doctors continued to prescribe pain pumps full of anesthesia.

Continue reading "FDA Calls for New Labeling for Anesthetics Used in Post-Surgery Pain Pumps" »

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As a defective prescription drug attorney, I am familiar with at least one older study linking a class of anemia drugs to potentially life-threatening blood clots. On Nov. 10, a study to be published in the Dec. 2 Journal of the National Cancer Institute confirmed that link. According to a Nov. 10 article from HealthDay, the study found that a class of drugs called erithropoiesis-stimulating agents (ESAs) doubled the risk of blood clots in cancer patients receiving the drugs during chemotherapy. Of those patients, 14.3% developed thromboembolism (blood clots big enough to block blood flow), while 9.8% of those not receiving an ESA developed it.

ESAs are typically prescribed to people undergoing chemotherapy -- of which anemia can be a side effect -- or people with chronic kidney disease. Common brand names for these drugs include Procrit, Epogen (both epoetin alfa) and Aranesp (darbepoetin alfa). They were approved in the late 1990s to reduce the need among chemotherapy patients for blood transfusions and are now widely prescribed. According to the article, U.S. ESA sales were $10 billion in 2006, and Medicare spent more on ESAs than on any other drug. However, the new study found no difference in number of transfusions between patients receiving ESAs during chemotherapy and chemotherapy patients not taking the drugs. Survival rates were also similar.

However, patients taking ESAs had an higher risk of developing veinous thromboembolism -- blood clots in veins big enough to block at least some blood flow. Specifically, they had a higher rate of pulmonary embolism and deep vein thrombosis, both of which can cause life-threatening complications. When a blood clot passes into the lungs in a pulmonary embolism, it can cause breathing problems, heart palpitations, abnormally low blood pressure, collapse and sometimes death. Deep vein thrombosis that doesn’t result in a pulmonary embolism can still cause swelling, pain and skin problems. Because of the risk of death, both are considered medical emergencies.

As a dangerous medication lawyer, I’m not sure whether it’s more disturbing that these drugs can cause sudden death from pulmonary embolism -- or that they don’t appear to do what they were approved to do. The study’s lead author, Dr. Dawn Hershman of the Herbert Irving Comprehensive Cancer Center in New York, said her results raise questions about the approval process and post-marketing research for ESAs. After the first studies connecting ESAs with blood clots, the Food and Drug Administration added a black box warning to their labels -- the most serious warning available -- disclosing the risk of blood clots and death and suggesting limitations on which patients should receive them. With this new study, I hope doctors and regulators seriously consider whether chemotherapy patients truly need an ESA before prescribing one.

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As a pharmaceutical liability attorney, I have noticed several reports of serious safety problems with the newest drugs intended for treatment of Type II diabetes. So I was disappointed, but not entirely surprised, to see a safety alert issued by the Food and Drug Administration Nov. 2 about problems with the diabetes drug Byetta (exenatide). According to a report from U.S. News and World Report, the FDA received 78 reports of kidney function problems in 4.5 years from people taking Byetta. In response, the agency announced major labeling changes for Byetta, including the addition of information on the kidney risks as well as advice to physicians to monitor patients for kidney problems.

Byetta, made by Amylin Pharmaceuticals Inc. of San Diego, is used to control blood sugar levels in Type II diabetes patients already using diet, exercise and some other diabetes medications. The FDA said its reports of problems with Byetta included 62 cases of acute kidney failure as well as 16 cases of renal insufficiency. Some, but not all, of the cases were in patients who already had kidney problems or were at risk for kidney problems. In addition to adding information on those cases to the label, the FDA said it would add information on kidney dysfunction to the prescription information for Byetta, so that patients can identify problems more quickly. It also asked health care professionals not to use the drug in patients with severe kidney problems and to use caution with patients with moderate kidney problems.

This is the second post-marketing report of serious side effects for Byetta. In 2007, the FDA issued a safety alert after receiving reports of acute pancreatitis in patients taking the drug. In 2008, the agency received at least four reports of death from pancreatitis, a sudden and painful inflammation of the pancreas. It can also reduce blood sugar to dangerously low levels (hypoglycemia).

As a dangerous drug lawyer, I am pleased to see the FDA take reasonably quick action on these reports of kidney problems. Renal failure is a type of organ failure with very serious implications for the patient. When the kidneys stop working, patients suffer pain and serious illness, as well as high risk of complications like anemia. Severely affected patients must depend on daily dialysis or hope for a transplant in order to stay healthy. And U.S. News and World Report said there were seven million prescriptions for the drug written during the 4.5-year period the FDA examined, which means millions of Americans are likely exposed to this side effect. When the risk is this serious, patients and their doctors have the right to know as much as possible about it.

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Back in April, I wrote on this blog about the withdrawal of the drug Raptiva (efalizumab) from the market for safety reasons. That medication, intended for treating psoriasis, was implicated for weakening the immune system and allowing users to contract a rare brain infection called progressive multifocal leukoencephalopathy. Now, PML is back in the news in connection with two other drugs -- Tysabri (natalizumab), a treatment for multiple sclerosis, and Rituxan (rituximab), which is for treatment of arthritis. The FDA is already watching both drugs for cases of PML. Now, the FDA has announced a new and slightly different case of PML in a patient taking Rituxan, and the European Medicines Agency, the EU’s FDA, is reviewing whether additional measures are necessary to make Tysabri safe.

The Tysabri review comes after 23 cases of PML were reported -- about twice as many as were thought to exist before. The U.S. manufacturer, Boston’s Biogen Idec, said it was already considering a labeling change that would tell consumers that their risk of PML increases the longer they take Tysabri. Ironically, PML resembles a much faster form of multiple sclerosis, a degenerative disease that attacks patients’ movement, vision, speech and cognition. In MS, the body attacks myelin sheaths that protect nerve cells, but the sheaths can be replaced, causing the disease to progress slowly over a number of years. In PML, the cells that make the myelin are destroyed. As a result, PML progresses quickly, often killing its patients within a year of diagnosis.

While the effects of PML may be confused with the effects of MS in patients taking Tysabri, the problem is substantially less likely for patients taking Rituxan, which is indicated for rheumatoid arthritis. The FDA announced Oct. 23 that it had received a report of a new case of PML related to Rituxan, its third reported case. In this case, a 73-year-old woman received one course of treatment with the drug, then developed symptoms of PML within four to six months. This case is different from the previous two, the FDA said, because the woman had not previously been treated with a type of cancer drug called a TNF inhibitor. The FDA said “information to date suggests that patients with [rheumatoid arthritis] who receive Rituxan have an increased risk of PML.”

As a drug injury attorney, I hope that doctors are seriously reconsidering writing new prescriptions for Rituxan and Tysabri. Rheumatoid arthritis and MS are both serious, life-altering diseases, but this is a case where the cure may be even worse. Aside from AIDS patients, who can fight PML with newer drugs that restore their immune functions, patients diagnosed with PML are statistically likely to die within a year of diagnosis. Those who survive may live with severe neurological disabilities. This is a terrible fate and a terrible thing to watch a loved one go through. If the manufacturers originally understated this risk-- or they negligently failed to examine it thoroughly -- they could be legally liable in multiple pharmaceutical injury lawsuits from around the U.S. and the world.

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Nearly seven months after the drug Phenergan was the center of a controversial U.S. Supreme Court ruling, the Food and Drug Administration has required a black box warning for the label of its generic version, promethazine. According to the Associated Press, the agency made the labeling change to warn patients about the possibility of gangrene if the drug is administered improperly -- the same issue at the center of the Supreme Court case.

Promethazine, an anti-nausea, anti-vomiting and sedative drug, is administered as an injection deep into muscle tissue. However, if it’s administered to an artery or under the skin instead, it can damage tissues so badly that the cells die, sometimes causing gangrene and amputation of the affected area. According to the FDA’s press release, the new label moves the warning about the possibility of gangrene from the package insert onto the outside of the package itself. It will also caution health care professionals to inject the drug deep into the patient’s muscle, and to give the injection slowly and at low concentrations to prevent promethazine from leaking from the veins into the surrounding tissue, where it can do damage.

The lack of strong warnings on the drug was the center of the Supreme Court case, Wyeth v. Levine. Patient Janet Levine sued drug company Wyeth after an injection of Phenergan caused the amputation of her right arm. She alleged that Wyeth failed to provide sufficient warning about the risk of gangrene. Wyeth argued that its labeling was sufficient because it had been approved by the FDA. The federal law allowing the FDA to regulate drug labeling preempts state law, the drug manufacturer argued, meaning that state juries like the one in Levine’s case should not be able to find that its labels are insufficient. This would have effectively ended nearly all lawsuits against drug manufacturers over this issue. However, the Supreme Court ruled 6-3 for Levine, saying Congress did not intend to preempt state juries when it established the FDA.

As a dangerous prescription drug attorney, I am pleased that the FDA took the next logical step after the Wyeth ruling -- confirming the need for a labeling change by ordering the strongest warning available. Tissue death, gangrene and resulting amputation are not common reactions to promethazine -- but when they happen, they change the lives of the victims forever. Losing an arm requires victims to relearn how to do nearly everything in life, from eating to dressing to driving. It also takes away careers and livelihoods; Levine, the plaintiff in the Supreme Court case, was a guitarist and pianist before she lost her arm. If it can prevent others from suffering from an irreversible, lifelong disability, this labeling change is worthwhile.

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Pharmaceutical company GlaxoSmithKline discussed burying studies linking antidepressant Paxil (paroxetine) to birth defects, Bloomberg News reported Sept. 15. The revelation came in the opening phases of a lawsuit against GlaxoSmithKline by Michelle David and her three-year-old son, Lyam Kilker, who claim Paxil is responsible for Kilker’s life-threatening heart defects. The plaintiffs and their dangerous prescription drug attorney claim GlaxoSmithKline knew Paxil could cause birth defects and intentionally withheld that information in order to protect the drug’s sales, estimated at $942 million in 2008. According to Bloomberg, the case is the first of more than 600 claiming that GlaxoSmithKline knew Paxil causes birth defects, but continued selling it anyway without notifying consumers, doctors or regulators.

The memo in question was written in 1997 by GlaxoSmithKline executive Bonnie Rossello, about the possibility of doing animal studies on the drug. “If neg[ative], results can bury,” Rossello wrote. The plaintiffs also claim the manufacturer knew when it bought the drug’s patent in 1980 that the previous owner had found evidence that Paxil caused birth defects in rats. Nonetheless, they said, GlaxoSmithKline resisted doing a study on its drug for almost 20 years to see why the young rats in that study died. In 1998, the plaintiffs said, GlaxoSmithKline reviewed its reports of Paxil side effects and found a high number of birth defects -- then deleted the relevant parts of the report and never notified the U.S. Food and Drug Administration. And in 2001, an internal report said birth defects in a patient’s fetus were “almost certainly” caused by Paxil use.

After a 2003 order from the FDA for more safety tests, the company acknowledged that Paxil increased the risk of birth defects. Nonetheless, a lawyer for the drug maker said at trial that it had not received reports of the specific defect Kilker has before he was born in 2005. Since 2003, several studies have shown that Paxil use during pregnancy increases the risk of heart defects in babies by 1.5 to 1.7 times. A study in the British medical journal The Lancet also found that babies born to mothers using Paxil had withdrawal symptoms, including convulsions. The drug’s labeling now warns of this risk, and the American College of Obstetricians and Gynecologists has recommended that pregnant women and women trying to become pregnant avoid Paxil.

As a defective prescription drug attorney, I will watch this and other Paxil cases closely. Heart defects in newborn infants are frightening and potentially life-threatening. Children with severe defects may need surgery or multiple-drug regimens to be well enough to live normal lives. This is a terrible challenge for any family to face -- and juries will likely sympathize with children who are ill through no fault of their own. That may be particularly true if plaintiffs can prove that GlaxoSmithKline knew or should reasonably have known about the link between Paxil and infant heart defects earlier. If these plaintiffs can prove the claims outlined in the article, I think they have a strong chance.

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Researchers who study the effectiveness and safety of asthma drugs are questioning the results of a new study, Reuters reported Aug. 19. The new study examines the safety of a class of inhaled asthma drugs called long-acting beta agonists, which include Serevent (salmeterol) and Foradil (formoterol); and, in combination with inhaled corticosteroids, Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide). The study was conducted by researchers including Dr. David Lang of the Cleveland Clinic Foundation -- but it was funded with an unrestricted grant from GlaxoSmithKline, the maker of Serevent and Advair. As a result, say independent researchers, the study’s conclusion -- that these drugs don’t increase asthma-related illnesses -- is not reliable.

For several years, scientists have suspected that long-acting beta agonists actually increase the chances of serious complications from asthma. In fact, one 2003 study showed that the chance of death was actually higher for asthma patients using the drug than it was for those taking only a placebo. Another study found that the risk is even greater for African-Americans, although it was not clear why that might be. The FDA updated the drugs’ warning labels to reflect that risk three times, in 2003, 2005 and 2006, and recommended in 2008 that long-acting beta agonists be banned as asthma medication.

The study by Lang and his colleagues examined that risk. They examined hospitalizations for asthma in Philadelphia between 1995 and 1999, then checked them against prescription rates for both short-acting and long-acting beta agonists. According to the findings, hospitalizations rose with short-acting beta agonist prescriptions, but fell with more prescriptions for the long-acting drugs. The researchers concluded that the study showed no evidence that long-acting beta agonists increase asthma-related illnesses.

Asthma drug researcher Dr. Christopher Cates of the University of London disagreed. He said the study design was unreliable, at least in part because researchers didn’t determine whether the drugs were prescribed for asthma. (As a dangerous drug attorney, I can add that correlation between two events does not necessarily mean that one caused the other, although dishonest people may try to imply otherwise.) Another independent scientist, Dr. Shelly Salpeter of Stanford University, said the association between long-acting beta agonists and asthma complications is clear from multiple studies. In fact, both doctors said, the medical community has moved on to examining whether these drugs are safe in combination with corticosteroids; recent evidence suggests that they are not.

As a pharmaceutical injury lawyer, I am not surprised that a study funded entirely by GlaxoSmithKline would draw conclusions favorable to GlaxoSmithKline’s drugs. There are 300 million people around the world who suffer from asthma, and Advair alone has $3.8 billion in annual sales. All of those profits and more would be lost to the drug maker if it is forced to remove Advair and Serevent from the market because of safety concerns. Nonetheless, evidence is growing that these drugs may actually raise the risk of a serious asthma-related illness, up to and including fatal illnesses. Under those circumstances, it is, at the least, highly irresponsible to sponsor studies that deceptively claim otherwise. If even a fraction of those 300 million people fall seriously ill because they were misled into believing long-acting beta agonists were safe, the drug maker could be responsible for thousands of deaths and catastrophic illnesses.

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Barr Laboratories is recalling one lot of its generic Adderall due to a serious manufacturing defect, the Los Angeles Times reported Aug. 14. The laboratory is recalling lot number 311756 of the 20-mg, 110-count bottles of Adderall, a mixture of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. The manufacturer started the recall after finding that some of the pills in the lot were oversized, which can lead to an overdose causing heart arrhythmia, heart palpitations, high blood pressure, anxiety, insomnia and other side effects. Patients who have this lot of the drug are advised to stop taking it and return it immediately to their pharmacy, or call Barr Laboratories for more information at 1-888-742-5578.

Adderall is a drug used in children and adults with attention deficit hyperactivity disorder (ADHD). It is a mixture of several salts from the amphetamine family of drugs, which also contains the street drug methamphetamine. Like methamphetamine, Adderall is a stimulant that can cause severe adverse effects in an overdose, including mental health problems as well as potentially serious effects on the heart and cardiovascular system. Barr Laboratories’ press release lists potential physical effects of an overdose such as increased heart rate, high blood pressure, heart palpitations, tremors, dizziness, insomnia and nausea. Possible psychological side effects of the oversized pills include anxiety, euphoria, mania and agitation.

Fortunately, the manufacturer and the FDA did not report hearing of any dangerous side effects from the oversized, defective pills. But as a dangerous prescription drug lawyer, I know ADHD drugs and stimulants generally have a troubled history when it comes to safety. Adderall and other stimulants are not prescribed to people with a history of heart problems, seizures or drug abuse because they can be dangerous or even fatal for all of those groups. Furthermore, studies have shown that they can cause changes in vision and stunt children’s growth, at least temporarily. And in 2006, an FDA advisory panel voted to put a black box warning on the drug’s label about potential cardiovascular and mental health side effects in children -- a recommendation the FDA ignored.

The current recall should not be a cause for alarm for all patients taking Adderall; only one lot is affected. But because an overdose of amphetamines can be very serious, patients who purchased the oversized pills are at risk of health- or life-threatening side effects. Like all drug manufacturers, Barr Laboratories is strictly liable for the damage its products cause if they have a manufacturing defect -- even if they didn’t know about the problem ahead of time. Any patients who are seriously harmed by the oversized pills would have the right to hold the manufacturer legally responsible with a defective prescription medication lawsuit.

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The FDA is studying data from ongoing safety tests of the asthma medication Xolair, the agency’s August 2009 MedWatch Safety Alert said. Xolair (omalizumab) is an injected medication that controls asthma in patients with year-round allergies who don’t respond well to inhaled treatments. The alert said the FDA has data showing that Xolair increases patients’ chance of developing cardiovascular problems, including potentially fatal heart attacks and strokes. The agency has not yet made a decision and suggests that patients continue taking the medication, but talk to their doctors about its risks and benefits and the ongoing study.

That study, named EXCELS, compares 5,000 patients taking Xolair to a control group not taking the drug. Preliminary results suggest that the group taking Xolair had a disproportionate rate of adverse events involving the heart and brain compared to the control group. Those adverse events included ischemic heart disease, heart arrhythmia, heart failure, high blood pressure, blood clots and strokes. Xolair already has a black box warning, the strongest available, warning patients about the risk of a life-threatening allergic reaction called anaphylaxis. That threat, while rare, led to a requirement that doctors administer the drug -- which was previously self-administered by patients -- and observe patients for two hours after.

As a defective prescription drug attorney, I suspect that another black box warning may be ordered if the study turns up strong evidence of a link between Xolair and cardiovascular problems. The FDA has already signaled that it plans to pursue safety issues more thoroughly than it did under the last presidency, and the problems the study allegedly turned up include potentially life-threatening and disabling health problems. A stroke can not only kill, but leave patients partially paralyzed or with permanent, lifelong problems with speech and memory. (That’s on top of the known risk of anaphylaxis, which can kill very quickly if the patient does not get treatment.) The drug is not used widely, but with side effects this serious, Xolair maker Genentech and distributor Novartis could face huge liability from patients who are killed or permanently disabled by what they thought was a life-saving allergy medication.

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The U.S. Food and Drug Administration has ordered the strongest safety warning possible for a class of prescription drugs called TNF blockers, HealthDay reported Aug. 4. The FDA ordered the warning for children and teenagers using these anti-inflammatory drugs after an analysis of current users showed that the drug increased their risk of cancer, including fatal cancer. The FDA said it was working with manufacturers to better understand the cancer risk of these drugs. It also included information in the black box warning about reports of psoriasis associated with TNF blockers.

The affected patients are children and teens using TNF blockers to treat juvenile rheumatoid arthritis, inflammatory bowel disorder, Crohn’s disease and other chronic inflammatory diseases. Common drugs that will get the new safety warning include Remicade (infliximab), Humira (adalimumab), Enbrel (etancercept), Cimzia (certolizumab pegol) and Simponi (golimumab). All of these drugs are tumor necrosis factor-alpha blockers or inhibitors, which means they stop the action of a body chemical that promotes inflammation of tissues. Too much of that chemical is believed to be responsible for the inflammation and tissue damage involved in conditions like rheumatoid arthritis, which can be crippling.

The FDA’s study found that children and teens using these prescription drugs had an increased risk of cancer, though they did not specify how much greater the risk was. The cancers began an average of 30 months after treatment, and about half of the cancers were lymphomas, a type of immune system cancer. Some of the cases were fatal. This study was launched in June of 2008, a month before the New England Journal of Medicine published the case of an adult woman who developed lung cancer after taking TNF blockers for Crohn’s disease. When she stopped the drug, her cancer vanished. A doctor with the Arthritis Foundation told HealthDay that patients should weigh the risks of taking TNF blockers against the benefits, which include preventing disability and deformation in children with juvenile rheumatoid arthritis.

The same doctor mentioned that patients with inflammatory illnesses are already at an increased risk of cancer. Given that fact, adding an even greater risk of cancer by using TNF blockers sends up red flags for me, as a dangerous prescription drug attorney. Current and future patients can talk to their doctors about risks versus benefits -- but for children and teens who have already developed cancer because of taking TNF blockers, it’s too late to make an informed decision. These kids may already have developed life-threatening lymphomas or other cancers, and their families may have racked up many thousands of dollars in medical bills to fight the cancer.

Continue reading "Black Box Safety Warning Ordered for Certain Children’s Drugs That Raise Risk of Cancer" »

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The U.S. Food and Drug Administration has ordered makers of a drug for digestive problems to add the strongest warning possible to its label, WebMD reported earlier this year. The “black box” warning will caution patients about the risk of developing a serious and potentially incurable muscle disorder called tardive dyskinesia after taking Reglan (metoclopramide). Patients with tardive dyskinesia have involuntary, repetitive muscle spasms, including pursing and smacking of the lips, grimacing, sticking out the tongue and rapid blinking. Patients taking Reglan who have noticed these effects are encouraged to contact the FDA to report any problems with the medication.

According to the FDA press release, two million Americans take some form of Reglan. It is used primarily to treat nausea and vomiting due to certain kinds of cancer treatments, infection, drug side effects and pregnancy, as well as for diabetics with digestion problems. Tardive dyskinesia is a known side effect of Reglan, which is why the FDA recommends that patients use the drug for no more than three months at a time. However, the agency ordered the more stringent warning after recent analyses found that Reglan is the most common cause of drug-induced movement disorders. The agency had also received continuing and spontaneous reports of patients developing tardive dyskinesia after using Reglan. Reglan was also the subject of a defective drug lawsuit in California, in which drug maker Wyeth was held liable for its failure to warn patients about the risk of tardive dyskinesia.

Tardive dyskinesia is a side effect of prolonged or high-dose use of dopamine antagonist medications, including antipsychotics and neurological drugs as well as Reglan and other gastrointestinal drugs. The condition may be mistaken for Parkinson’s disease, but while Parkinson’s patients have trouble moving, tardive dyskinesia patients have trouble not moving. These patients experience involuntary, rapid and repetitive movements, especially movement in the face, fingers and extremities. The movements may or may not disappear after the drug is stopped, and they may take years to subside. There is no known cure for tardive dyskinesia, which is why medical professionals focus on preventing it by limiting the use and dosage of the drugs that cause it.

As a dangerous drug injury attorney, I noticed that Reglan is part of a class of drugs normally used to manipulate the brain chemistry of patients with menal illness or neurological disorders. That’s one reason why Reglan’s side effects include tardive dyskinesia and other neurological symptoms, from drowsiness and dizziness to neuroleptic malignant syndrome. This is too high a price to pay for relief from nausea and vomiting. As the FDA said, this black box warning on Reglan should help patients and doctors make an informed decision about whether the risks are worth the benefits. But for the millions who have already taken Reglan, it may be too late. If an investigation shows that Wyeth and others failed to adequately warn patients of the risk of tardive dyskinesia before the labeling change, patients who develop this terrible, incurable disability have the right to sue the drug makers.

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The U.S. Food and Drug Administration has required the strongest warning label a drug can have for two painkillers, the Washington Post reported July 8. Darvon (propoxyphene) and Darvocet (propoxyphene with acetaminophen) got the increased warning, the agency said, to reduce the risk of fatal overdoses. The new label will warn patients about the risk of an overdose, and accompanying packaging will include a medication guide emphasizing the risks of not using the drug as directed. In addition, the FDA has ordered a new study of the effects of a propoxyphene overdose on the heart.

The agency’s action came a few weeks after the European Union’s drug regulator voted to phase out Darvon and Darvocet for safety reasons. In the U.S., the activist group Public Citizen petitioned in 2006 to take propoxyphene off the market, saying it is a relatively weak painkiller with too many side effects. In fact, an advisory panel for the FDA voted in 14 to 12 January that the drug should be withdrawn from the U.S. marketplace. The FDA decided not to follow its panel’s advice (which it is free to do) saying the benefits of the drugs outweighed the risks.

According to the Post, the problem with propoxyphene is its effect on the heart. Propoxyphene can decrease the patient’s heart rate and raises the risk of a potentially fatal heart arrhythmia, which has led to fatal overdoses. Because it is also a weak opioid painkiller with potential for addiction, watchdogs may be concerned about its potential for overdoses among drug abusers. The FDA has recorded 91 cases of fatal overdose since 1969, but overdoses are widely thought to be underreported. In the form of Darvocet, which combines propoxyphene with acetaminophen, overdose also carries the risk of fatal liver poisoning.

Darvon has been on the U.S. market since 1957 -- and that’s what concerns me, as a dangerous prescription drug attorney. Though it’s not nearly as popular as prescription painkillers like Vicodin, propoxyphene is prescribed about 22 million times a year. Even if only a tiny fraction of patients overdose each year, that’s a huge number of people over the decades who may have been killed by a drug they trusted to help them. That means the pharmaceutical companies that make and sell Darvon and Darvocet could face thousands of pharmaceutical injury lawsuits from the families of people who were wrongfully killed.

Continue reading "FDA Adds Black Box Warning to Painkillers Darvon and Darvocet Because of Risk of Fatal Overdose" »

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The U.S. Food and Drug Administration announced July 1 that it would require the strongest safety warning possible on the labels of prescription smoking cessation drugs Chantix (varenicline) and Zyban (bupropion, also sold as Wellbutrin), the Washington Post’s The Checkup blog said July 1. Both are sold to people who are trying to quit smoking, but have come under fire as users and scientists began to discover serious psychiatric side effects. The black box warning will tell patients that the drugs carry an increased risk of depression, hostility, mood changes and suicidal thoughts. Manufacturers Pfizer (Chantix) and GlaxoSmithKline (Zyban) are also required to run new clinical trials examining how often these mental health problems occur in users.

The move came after multiple reports of depression, increased depression and other behavioral changes that started shortly after taking the drug and stopped shortly after discontinuing use. An FDA newsletter said it received 153 reports of suicidal “adverse events” for Chantix and 75 for Zyban since their approval for use as anti-smoking drugs. This was true at the recommended dose, for people both with and without a previous history of depression. However, the FDA noted that some of these side effects may also be associated with nicotine withdrawal. It also told users not to stop the drugs cold turkey, since this can cause side effects and smoking is a serious health risk -- just to be aware of the risk and talk to their doctors about problems.

I’m sorry to say that this is not the first report of mental health side effects I’ve seen as a dangerous drug attorney. Chantix in particular (called Champix overseas) has been under investigation since 2007, shortly after its fast-tracked approval the year before. In addition to depression and suicidal thoughts, Chantix users have reported agitation, aggression, homicidal thoughts, bizarre dreams and psychosis. Zyban users have reported similar problems, including hallucinations -- and when it is sold as Wellbutrin, bupropion already carries a black box warning about suicide.

The FDA’s action doesn’t take these drugs off the market, but the black box requirement is a powerful warning to consumers that they should be use caution. As a defective drug lawyer, I have seen several accounts of people who suffered serious psychiatric changes after starting one of these quit-smoking drugs, most recently a Pennsylvania man who said taking Chantix might have something to do with his attack on his wife. Like all manufacturers, drug makers have a legal responsibility to offer us products that are safe and free of defects. When they fail, consumers who are hurt can hold them legally and financially responsible for the results. If it becomes clear that Pfizer and GlaxoSmithKline were selling drugs without a clearly necessary warning -- or even knew of the side effects ahead of time -- they could be hit with multiple pharmaceutical injury lawsuits.

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On Thursday, by order of the U.S. Food and Drug Administration, U.S. Marshals raided generic drug company Caraco's factories and seized more than 30 of the 40-odd medications it markets. The seizure was ordered after the FDA found manufacturing problems at all three of the company’s plants in Detroit, Michigan.

Caraco is no stranger to FDA-related controversy. Indeed, it has had several high-profile recalls of its medications just in the past year, all of which exposed it to multiple dangerous drug lawsuits. These recalls included the popular diabetes drug metformin (generic for Glucophage), and the heart drug digoxin, the latter of which allows Caraco to hold a fifth of the U.S. market. Both products were recalled due to concerns about accidental variations in the pills' sizes.

Despite the FDA's drastic measures, the director of its drug division's office of compliance has said that patients taking generic drugs made by Caraco should continue to take them, because all of the defective drugs had been recalled or seized. This seems an interesting instruction, considering how great the damage could be if she is wrong. Digoxin, a derivative of the poisonous plant foxglove, is known to be toxic and has a narrow margin between beneficial and lethal amounts. Improperly sized digoxin tablets can cause heart instability and even death, particularly in patients with kidney failure. Last year, a different generic drug company, Actavis Group, recalled its generic digoxin medication due to concerns that some of the tablets had been manufactured twice as thick as the company intended. According to the FDA, "several reports of illness and injuries" were linked to Activis pills last year.

Caraco's products also include a generic form of epilepsy drug Tegretol, a pain reliever called tramadol/APAP, and many others. A full list of the company's defective products can be found on the FDA's website. Generic defective drugs can be even more dangerous than their brand-name counterparts, as the manufacturer's name does not call attention to itself. However, it should always be listed, so please check the labels of all your generic medications. If you or someone you love has experienced serious ill effects or untimely death after taking a Caraco-manufactured product, please contact a St. Louis pharmaceutical liability lawyer to learn more about your rights and your potential legal claim. Innocent consumers who fall victim to mistakes by Caraco or any other drug company should be heard -- and, if appropriate, compensated for their physical, emotional and financial losses.

Based in St. Louis, Missouri, The Lowe Law Firm's pharmaceutical injury lawyers represent clients in Missouri, southern Illinois and across the country who have been hurt by defective prescription and over-the-counter medications. If you or someone you care about has been harmed by a dangerous drug, and you would like to learn more about your rights and options, please contact the Lowe Law Firm online, or call us toll-free at 1-877-678-3400 for a free, confidential consultation.

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On Tuesday, the FDA shocked thousands of consumers with an advisement to stop using Zicam cold remedies. The announcement cited links between three Zicam products -- Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids' Size -- with the loss of sense of smell. The culprit ingredient in these so-called "natural" Zicam Products is zinc, a mineral that scientists say has been known since 1938 to damage nerves in the nose needed for smell. According to the Washington Post, zinc also has apparently been used to destroy sense of smell in laboratory animals.

Also called anosmia, the loss of sense of smell can be permanent. This amounts to the loss of one of your five basic senses. Without sense of smell, not only are you unable to experience full quality of life by smelling pleasant scents, but your ability to detect dangerous fumes or smoke is also greatly impaired -- in other words, a properly functioning nose could save your life. Your sense of taste is also greatly diminished when you can't smell, making you much more likely to ingest spoiled food, or food tainted with harmful substances.

The advisement came after more than 130 reports had been submitted to the FDA about a loss of sense of smell in patients who used one of the three Zicam products. Some reports came after several doses of Zicam, but many of these people said their anosmia occurred suddenly, after just one dose. In response to this alarming body of evidence, the FDA sent Matrixx Initiatives, manufacturer of Zicam products, a letter of warning stating that the products could no longer be marketed without FDA approval.

The FDA has stated that Zicam Cold Remedy was never formally approved because it is part of a group of remedies called homeopathic products, formulations that typically use small doses of "natural" active ingredients including herbs, minerals and flowers. This may be the FDA's policy, but as a southern Illinois product liability lawyer I would like to point out that this is no excuse for laxity in product testing. "Natural" is a far cry from "harmless."

The letter also stated that the products were not properly labeled to reflect the risk of anosmia that has been associated with them. You might think this was all news to Matrixx, or that they thought that 130 cases somehow weren't enough to merit labeling their product with a safety advisement. The fact is that they have already settled more than 400 lawsuits about this very thing, including a giant $12 million lawsuit in 2006. The company also has received more than 800 anosmia complaints, which the FDA recently asked them to surrender. The company did not comply.Speaking as a St. Louis pharmaceutical liability attorney and as a human being, a company neglecting to account for that many injuries in the name of profit is positively appalling.

The FDA says it is especially concerned about intranasal zinc use in children, since children might lose sense of smell but be less likely to communicate the condition to an adult. Fortunately, the Kids' Size Cold Remedy Swabs had already been discontinued prior to the FDA's announcement. Matrixx has said it will withdraw its dangerous products from stores, but extensive damage has already been done. With Zicam sales in the millions, the chances are good that someone close to you has used this product, or considered using it, at least once. Worse, reports are now surfacing that Zicam products are not the only "homeopathic" products out there that are causing serious side effects. These problems could affect millions of Americans -- all of whom would have a legal claim against the products’ manufacturers

Zicam products reeled in about 40 percent of Matrixx's $111.6 million in sales last year. While Matrixx decides what its next move will be, the FDA has advised people who have experienced any sense of smell loss or other problems after use of any of the three Zicam products to consult their health care professional. I would add that they should consult a Missouri dangerous drug attorney directly after. The loss of one of life's most basic and crucial senses is a possibility no one -- not even Matrixx -- can afford to ignore.

If you or someone you love has experienced a loss of sense of smell and has used Zicam products, or has experienced serious side effects after taking any product labeled as "homeopathic," please contact The Lowe Law Firm right away. In a dangerous drug injury lawsuit, you can claim payment for all the medical treatment related to the supplement’s defects, plus lost wages and compensation for your injuries.

Based in St. Louis, Missouri, our pharmaceutical liability lawyers represent clients across the nation who have been hurt by defective medications and over-the-counter remedies. If you would like to learn more about your rights and options, please contact the Lowe Law Firm online, or call toll-free at 1-877-678-3400 for a free, confidential consultation.

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The FDA made an official statement today, saying it has requested class of asthma drugs called leukotriene modifiers be labeled with a "precaution" warning of potential psychiatric side effects, including suicidal thoughts and behavior. This family of drugs includes zileuton, marketed by Cornerstone as Zyflo and Zyflo CR; zarfirlukast, marketed by AstraZeneca as Accolate; and montelukast, marketed as Singulair, Merck & Co.'s number-one-selling drug.

In March of last year, the FDA began an ongoing safety review of a possible association between suicidal tendencies and leukotriene modifiers. In early January, the FDA said clinical trial data suggested that the products were not associated with an increased risk of mood changes or suicidal behavior. But in April, as the agency completed a review including not only clinical trial data but also post-marketing reports, it began to change its tune. The post-marketing reports included cases of neuropsychiatric events including agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior including suicide, and tremors.

Singulair has been associated with psychiatric side effects for some time; Merck began labeling Singulair to reflect those possible side effects in March 2007. In response to today's FDA request, Merck stated that precautionary language is already included in Singulair's labeling, and that the language will simply be moved from a section labeled as "side effects" to a higher section labeled as "precautions." Merck also says it will provide health care providers with informative leaflets and communicate these latest findings to prescribing professionals face-to-face. Speaking as a St. Louis defective drug lawyer, I believe Merck not only should be held to these claims, but also should be held accountable for keeping consumers informed. AstraZeneca and Cornerstone have also said they will add precautionary language to their drugs' labeling; they too should be held to their claims.

According to Reuters, analysts from Morningstar and BMO Capital Markets say the distinction between side effect advisements and precaution labeling will have little effect on sales. As a Southern Illinois harmful drug attorney, I say this is all the more reason for consumers to remain vigilant. That same article says Singulair's U.S. sales are estimated at $4.4 billion for 2009; if the FDA is reporting an association between suicidal thoughts and these drugs in documented cases, imagine how many undocumented cases exist in the U.S. today.

If you or a loved one have had suicidal thoughts or other psychiatric side effects while taking Singulair, Accolate, Zyflo, Zyflo CR, or any of their generic equivalents, you have rights, and the Lowe Law Offices can help you protect them. With offices in St. Louis, Missouri and Belleville, Illinois, our pharmaceutical liability lawyers represent people who have suffered serious illnesses or injuries because they took a dangerous medication. In a defective drug lawsuit, you can win back the cost of the drug and all of the treatment it necessitated, as well as compensation for serious injury, permanent disability or the loss of a loved one. If this sounds like your situation, we can help you learn what your options are at a free, confidential consultation. To set one up, please contact the Lowe Law Firm online or call us toll-free at 1-877-678-3400.

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On June 4, the U.S. Food and Drug Administration issued a warning to healthcare professionals associating the risk of liver damage and failure with the use of the anti-thyroid drug propylthiouracil. The drug is prescribed for the treatment of Graves' disease, an autoimmune disorder that leads to overactivity of the thyroid gland. The FDA's notification linked the use of propylthiouracil to serious liver injury, including liver failure and death, in both adult and pediatric patients.

"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research, in the report. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

The FDA discussed these findings on April 19, 2009 with the American Thyroid Association (ATA) at a public workshop on propylthiouracil-related liver toxicity in Washington, D.C. According to the FDA, a total of 32 cases of serious liver injury associated with the use of propylthiouracil were reported to the FDA's Adverse Event Reporting System, from when the system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant. In contrast, only five cases of serious liver injury were identified for methimazole, which was approved for marketing in 1950. All five cases were in adult patients, and three resulted in death.

The report did not definitively conclude that there was a causal relationship between propylthiouracil and liver toxicity, nor did it advise healthcare professionals to stop prescribing the product. However, the FDA did advise caution in prescribing the drug, and that each case should be examined individually. For example, because a rare birth defect has been reported with methimazole and not with propylthiouracil, propylthiouracil may be more appropriate for patients with Graves' disease who are in the first trimester of pregnancy, the report said.

I am pleased that the FDA has brought this issue to the attention of the ATA and issued an official public warning on its website. However, as a Missouri dangerous drug attorney, I must stress that these are only the first steps of many that should be taken to protect patients from the potential negative effects of this drug. Drug companies bear a great responsibility to take the initiative in keeping consumers current on the risks of the products they sell. This means proper labeling, warnings and marketing that properly reflects the risk entailed in using their product. If they fail to do those things, they can be held legally responsible for any injuries that result, through a pharmaceutical injury lawsuit.

The FDA said it is continuing to monitor these serious reported adverse events, and is working to make changes to the propylthiouracil prescribing information, particularly for use in pediatric patients. It also said that it intends to update its information on this issue when additional information or analyses become available. In the meantime, FDA says, adverse reactions or quality problems experienced with use of the propylthiouracil may be reported to the FDA's MedWatch Adverse Event Reporting program. Their contact information is available online.

Speaking as a Missouri dangerous drug lawyer, I feel it is especially important to address injuries caused by drugs, including those in generic circulation, as soon as possible. Since this particular medication has been marketed for quite some time -- since 1947, according to the FDA -- millions of Americans could have suffered these adverse effects already. It is important for those people to know what their rights are. That's why, even if there already is an existing class action suit against a particular drug that may have harmed you, you should contact The Lowe Law Firm immediately for a free, confidential consultation. The personalized attention you receive will help you to determine your specific rights and any potential case you may have.

Based in St. Louis, The Lowe Law Firm is a national law firm that specializes in representing people who have been injured by, or lost a loved one to, dangerous prescription drugs. Our Missouri defective drug attorneys represent people in the Midwest and across the United States. To set up an appointment with an experienced defective prescription drug attorney, please contact us today through our website, or call us toll-free at 1-877-678-3400.

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In a meta-analysis of 17 studies, researchers have found that the cancer drug Avastin substantially increases the risk of developing holes in the stomach and intestines, U.S. News & World Report said May 25. Researchers looked at 17 studies of Avastin, none of which have proven a significant association between the drug and perforations in the gastrointestinal tract. However, in their analysis, the researchers at Stony Brook University Cancer Center in New York found that patients were twice as likely to develop perforations when they took Avastin, and that the rate of perforations went up as the dosage did.

Avastin (bevacizumab) is approved in the United States to treat several types of cancer. In fact, the FDA in early May approved the drug for treatment of brain cancer. It attacks cancerous tumors by preventing new blood vessels, which keep cancer tissue alive, from forming. In the Stony Brook study, researchers looked at 17 studies involving nearly 13,000 patients who received Avastin along with chemotherapy. Those who received 2.5 milligrams of Avastin were 61% more likely to develop perforations than those not taking Avastin. At twice that dose, 5 milligrams, patients were 167% more likely to develop a perforation. The risk was highest in patients with coleorectal and renal cancer and lowest in those with pancreatic cancer.

Perforations in the stomach and bowels are a serious and potentially life-threatening medical emergency. When these holes develop, they allow stomach acids, food and feces to leak from the organs where they belong into the abdomen. This leads to a bacterial infection of the abdomen called peritonitis. Patients feel abdominal pain that gets worse when they move, nausea, vomiting and sometimes fever. Doctors generally must perform surgery to close the hole and wash away the matter that leaked.

As a Missouri prescription drug injury attorney, I am disappointed to learn that there’s accuracy to reports of Avastin’s dangers. This is the first strong evidence connecting Avastin to stomach and bowel perforations, but other studies have turned up evidence for the association. In fact, the drug was approved for use in breast cancer patients over the objections of the FDA’s own panel of experts. Avastin didn’t seem to prolong lives, they argued, so those and other side effects may not be worthwhile. Nonetheless, it was approved and now carries a black box warning, the strongest available, about its potential to cause gastrointestinal problems.

If you are taking Avastin and you believe it’s responsible for holes in your digestive tract that led to a medical emergency, you should call The Lowe Law Offices as soon as possible. People should never be injured or killed by prescription drugs that are supposed to help. If the drug’s manufacturer failed to warn patients and the public about this risk, patients who were harmed have the right to sue the drug manufacturer for all of their physical, financial and emotional injuries. That includes the cost of more medical care and all other costs related to the injury, as well as the physical pain, emotional trauma and any death or disability caused by the defective drug.

Based in St. Louis, the Lowe Law Offices is a national law firm specializing in representing people who were hurt by dangerous prescription drugs or lost a loved one. Our Illinois defective drug lawyers represent people in the Midwest and around the United States. And we offer free, confidential consultations, so you risk nothing to learn more about your rights and any potential case. To set up an appointment with an experienced dangerous prescription drug attorney, please contact us online or call toll-free at 1-877-678-3400 today.

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Federal regulators and pharmaceutical company Baxter International are investigating the cause of two deaths linked to blood-thinning drug heparin, the Wall Street Journal reported May 11. Two patients at a hospital in Lewes, Delaware died after using the heparin, and a third suffered unspecified medical problems; a spokeswoman for Baxter said their symptoms include intracranial bleeding. A hospital administrator told the newspaper that the problem had not yet been identified, but the use of heparin was the only thing they found tying the three cases together.

This is the second serious safety problem in two years for heparin and Baxter. Heparin is a blood thinner, used to treat dangerous blood clots, certain heart problems and people on life support. Contaminated heparin imported from China killed 81 people and sickened 785 more in 2008, sending them into shock and dangerously lowering blood pressure. The culprit was oversulfated chondroitin sulfate -- a supplement that is cheaper than heparin but mimics its effects, suggesting that it was used intentionally to cut costs. In response, Baxter and other manufacturers were forced to recall their versions of the drug. However, the article noted, the drug in the current outbreak comes from a North American source and patients’ symptoms are different.

As a dangerous prescription drug attorney, I hope regulators can find the problem and recall any tainted medication before more patients fall ill. The symptom mentioned in the article, intracranial bleeding, is the medical term for a hemorrhage inside the skull, including in the brain. This is considered a medical emergency because it can create pressure inside the skull that leads to brain damage -- and thanks to the heparin, the bleeding won’t be stopped by the body’s natural blood clotting ability. Patients with the serious medical problems treated with heparin are already weak, and they tend to be older -- those who died in Delaware were 64 and 71. A drug that causes severe pressure on the brains of these patients could kill them or leave them with permanent brain damage.

Based in St. Louis, The Lowe Law Firm represents clients throughout the Midwest and the United States who have been seriously harmed by a defective pharmaceutical product. Our defective medication lawyers help people who fell ill or lost a loved one to a dangerous drug hold pharmaceutical companies legally responsible for their actions. In a drug injury lawsuit, you can claim compensation for a death, serious illness or permanent disability, as well as compensation for all of the medical costs caused by the drug’s flaws. To learn more about how you can take action at a free, confidential consultation, please contact The Lowe Law Firm online today or call us toll-free at 1-877-678-3400 from anywhere in the United States.

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The U.S. Food and Drug Administration has warned consumers that they should immediately stop using an over-the-counter diet aid called Hydroxycut, the Associated Press reported May 1. The dietary supplement is associated with serious liver problems, the article said, including the death of a teenaged boy. Its maker, Iovate Health Sciences, has agreed to recall all 14 Hydroxycut products. Consumers who have any of those products should return them to the store where they were purchased, an FDA press release said, and report any negative effects of using the supplement to their doctors and the FDA. More information from Iovate can be found at HydroxycutInformation.com.

Hydroxycut is one of the most popular weight-loss supplements on the market, selling 9 million packages last year according to the Associated Press. The FDA recalled it after receiving 23 reports of serious liver problems in otherwise healthy people, including the death of a 19-year-old young man from liver failure. (Iovate disputes that Hydroxycut was responsible for the death.) Patients using the recommended amount of the supplement have reported jaundice (a yellowing of the skin), seizures, heart problems and a form of muscle damage called rhabdomyolysis, which can lead to kidney failure. Symptoms of serious liver problems include jaundice, brown urine, excessive tiredness, nausea and vomiting, itching and loss of appetite.

It is unclear which ingredient in Hydroxycut is behind the liver problems, the Associated Press said. The FDA does not have the power to review or test supplements before they go on the market, and Iovate has changed the supplement’s formula several times. However, a safety researcher interviewed by the Associated Press said the problem may be a fruit enzyme called hydroxycitric acid, which has been linked to liver problems in a scientific study.

As a Missouri dangerous drug attorney, I fear that this may only be the beginning of larger problems with this supplement. Hydroxycut is one of the most popular weight-loss supplements on the market, selling tens of millions of units over seven years. With so many users, it’s possible that far more than 23 users have encountered problems, but not connected them to using the supplement. Unfortunately, this is especially likely because the FDA has little regulatory power over dietary supplements. Instead, it must rely on post-consumption reports of problems from users of the supplements, and many consumers -- or their doctors -- don’t think to report their problems right away. In fact, the death believed to be related to Hydroxycut took place in 2007, but was reported only in March.

If you are one of the thousands of Americans who has used Hydroxycut and you now believe it’s responsible for serious health problems, you have legal rights. In a dangerous drug injury lawsuit, you can claim payment for all the medical treatment related to the supplement’s defects, as well as lost wages and compensation for your injuries. The Lowe Law Firm can help. Based in St. Louis, Missouri, our pharmaceutical liability lawyers represent clients around the nation who have been hurt by defective medications and dietary supplements.

If you would like to learn more about your rights and your options at a free, confidential consultation, please contact the Lowe Law Firm online or call toll-free at 1-877-678-3400 today.

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A court has ordered Neligen Pharmaceuticals and its parent company, Advent Pharmaceuticals, to immediately cease distributing more than 50 of its drugs. According to an April 10 Associated Press story, the U.S. Food and Drug Administration has a permanent injunction against the companies, barring them from manufacturing and distributing drugs that are adulterated, misbranded or not approved by the FDA. The drugs are mainly prescription cough and cold medicines -- but none have gone through the FDA approval process, so their safety, labeling and effectiveness are all in doubt.

According to the FDA press release, the companies (which also do business as Unigen Pharmaceuticals Inc.) agreed to a consent decree that requires them to destroy all of the drugs they currently have and stop manufacturing any new medications without FDA approval. They must hire outside experts to advise them on complying with regulatory standards, and may not resume operations until they have written permission from the FDA. After they do, the FDA may order them to stop their operations at any time if it finds a regulatory violation. The agency may fine the companies $1,000 per violation and up to $5,000 per day for any continuing legal violations.

As a defective prescription drug attorney, I am pleased to see the FDA cracking down on drug companies that abuse the public’s trust. Most of us assume that a drug wouldn’t even be on the market without FDA approval, so we trust that prescription medications are safe to use and adequately labeled. Companies that illegally bypass the FDA approval process betray that trust and expose consumers to potential serious injury from defective drugs or unannounced drug interactions. As a dangerous prescription medication lawyer, I have seen too many pharmaceutical companies’ cynical marketing tactics to believe that they would all be immune from the temptation to cut costs if they were not held accountable.

Based in St. Louis, The Lowe Law Firm represents people in Missouri, southern Illinois and throughout the United States. Our pharmaceutical liability lawyers sue on behalf of people who have lost a loved one or been seriously harmed because of a prescription or over-the-counter medication they thought they could trust. In these defective drug lawsuits, victims can win the money they need to pay for medical care or other bills related to the tainted medication; replace lost wages while they are out of work; and compensate them for a serious injury or illness, permanent disability or loss of a loved one. To learn more at a free, confidential consultation, please contact the Lowe Law Firm today.

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Pharmaceutical company Genentech announced April 8 that it would remove its drug Raptiva (efalizumab) from the market for safety reasons. Raptiva is an injectable medication given weekly to patients who have psoriasis, a chronic skin condition. According to Forbes magazine, the move came almost two months after the U.S. Food and Drug Administration confirmed the medication’s link to a rare but deadly disease called progressive multifocal leukoencephalopathy, a viral infection of the brain. Patients using Raptiva are strongly encouraged to contact their doctors right away to discuss alternative treatments.

Ironically, the problems with Raptiva may stem from its effectiveness. Psoriasis is a chronic, lifelong condition that produces raised patches of scaly or inflamed skin. Doctors are not sure what causes it, but many believe it’s an autoimmune disorder in which an overactive immune system produces too many skin cells. Raptiva addresses the problem by partially suppressing the immune system -- stopping white blood cells from reaching tissues. Because of the suppressed immune system, Raptiva carries a risk of side effects including infection with viral meningitis and fungal disease.

Most recently, the FDA has discovered that it also raises the risk of progressive multifocal leukoencephalopathy (PML), a disease caused by infection with a common virus. Authorities believe most people have this virus, but it is latent in people with healthy immune systems. The most likely victims are people with immune problems, such as AIDS, or who are on immunosuppressant drugs after a transplant. PML inflames the white matter of the brain, destroying the myelin sheath on nerve cells and causing weakness, paralysis, blindness, speech impairments and eventually death. It resembles multiple sclerosis, but progresses much more quickly. There is no known cure.

Thus far, the FDA has identified two confirmed cases of deaths from PML in Raptiva patients, and suspects PML in a third death. A fourth patient has PML but has not died. Since October of 2008, the agency has revised the drug’s labeling twice and issued a public advisory once on the risk of PML. During that time, the European Union’s equivalent to the FDA has suspended all sales of the drug. Genentech is working with other regulatory agencies to inform them about Raptiva’s withdrawal from the U.S. market, but it has not stopped worldwide sales. According to Forbes, 46,000 people around the world have used Raptiva since 2003.

I applaud Genentech for doing the right thing and withdrawing this potentially deadly medication from the market. But as a dangerous prescription drug attorney, I wonder how long the company has known about this risk and what measures it took to detect it. Accidents happen, but I know that some drug companies are willing to suppress unfavorable safety information or manipulate scientific studies to ensure that their sales stay high. If investigation shows that Genentech knew about the risk, or even failed to do adequate testing, the manufacturer would be legally liable for all of the deaths and deadly illnesses that resulted. That could mean millions of dollars’ worth of defective prescription drug lawsuits.

Based in St. Louis, the Lowe Law Firm handles dangerous pharmaceutical legal claims throughout the United States. Our defective drug lawyers represent people who have lost a loved one or been seriously hurt because they trusted the wrong prescription drugs. If you are in this situation and you’d like to learn more about your options, we offer free, confidential consultations. To set one up, please contact the Lowe Law Firm online today or call 1-877-678-3400.

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An email sent by an official at drug maker AstraZeneca admits that the company suppressed three clinical trials of its drug Seroquel because of unfavorable results, Bloomberg News reported Feb. 27. The message was revealed as part of an ongoing series of pharmaceutical injury lawsuits alleging that AstraZeneca knowingly failed to warn customers that Seroquel could cause diabetes and related health problems. In the December 1999 message, AstraZeneca official John Tumas told colleagues that the company “cherry-picked” data from one Seroquel study and failed outright to publicize two others that were unfavorable to its product.

Seroquel, an “atypical” antipsychotic, is approved to treat schizophrenia and bipolar disorder. Originally thought of as a vast improvement over older psychiatric medications, it came under fire in 2004, when a group of medical research organizations named it as one of six antipsychotics (along with Risperdal and Zyprexa) that promote diabetes, high cholesterol and obesity. At least 9,000 lawsuits have been filed alleging that AstraZeneca failed to warn patients of this risk. Many also allege that the company promoted its drug for illegal off-label uses. Spokesman Tony Jewell told Bloomberg News that the company acted responsibly and appropriately in its research and marketing.

The unsealed documents suggest that not everyone agrees, according to Bloomberg. In the 1999 email, Tumas chastised company officials for not disclosing the full results of the “cherry-picked” study, suggesting that the company’s reputation for ethical behavior was in danger. In another unsealed message, AstraZeneca official Richard Lawrence said the company had engaged in a “great smoke-and-mirrors job” with U.S. and Canadian regulators. And documents from 2000 show that company officials knew that the drug was linked to high blood-sugar levels, even though a 2000 FDA filing from the company said it had no documented evidence of a relationship between Seroquel and diabetes.

The Lowe Law Firm is actively pursuing lawsuits over injuries from taking Zyprexa, another of the atypical antipsychotics under fire for its connection with diabetes. If you or someone you care about has developed diabetes, obesity or another serious health problem from taking Seroquel, we would like to hear from you. In a successful defective drug injury lawsuit, you can win compensation for all medical bills related to an injury from Seroquel, as well as compensation for living with a serious health condition caused in part by a company’s failure to warn you of the dangers. Based in St. Louis, Missouri, the firm represents people with serious defective drug injuries around the U.S. To set up a free, confidential consultation, please call toll-free at 1-877-678-3400 or contact us online.

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As a pharmaceutical injury lawyer, I was delighted with the U.S. Supreme Court’s March 4 ruling that drug manufacturers may not escape legal liability simply because their warning labels comply with FDA regulations. Wyeth v. Levine (06-1249). As the New York Times reported, the court ruled 6-3 that there is no implied preemption in federal law that would stop state juries from hearing drug injury lawsuits. The case was closely watched by pharmaceutical companies as well as drug injury lawyers around the country, because it had the potential to stop all drug injury claims, no matter how valid the claim or serious the injury.

The case was brought by Vermont resident Diana Levine, who visited a health clinic for migraine headache treatment. For her nausea, she was given an injection of Phenergan, a drug made by Wyeth. Phenergan is safe when injected into a vein, but causes swift and irreversible gangrene when exposed to blood in arteries. The assistant at the clinic made a mistake, and Levine lost her hand and lower arm -- and her livelihood as a musician. She sued and settled with the clinic, but also sued Wyeth, arguing that the manufacturer failed to sufficiently warn users about the risks of administering Phenergan incorrectly.

At trial, Wyeth argued that it should not be held responsible for Levine’s injury because it had followed all of the FDA labeling regulations that applied to the drug. It said the court should find that federal law preempts state claims through implied, not explicit, language. The Supreme Court rejected that argument, saying that Congress had explicitly stated that several federal laws preempt state laws and had the opportunity to include such language in drug regulations -- but chose not to. In fact, wrote Justice John Paul Stevens, the FDA welcomed dangerous drug lawsuits as a complement to its own work until 2006, when it underwent “a dramatic change in position” under the Bush Administration. He also criticized the FDA at length for its toothlessness in recent years.

As a dangerous prescription drug lawyer, I am delighted with this ruling, which ensures that people who have suffered permanent injury or lost a loved one to a defective medication can continue to seek justice through state courts. If the court had found that federal law does preempt state claims, it would have eliminated many valid pharmaceutical liability lawsuits brought by seriously hurt people. The painkiller Vioxx, for example, became the subject of thousands of lawsuits after it was revealed to quadruple patients’ chances of serious heart attacks and withdrawn from the market amid allegations that drug maker Merck knew about the problem long before it took action. None of those people would be able to hold Merck responsible for their injuries, or the deaths of their loved ones, if the preemption argument had prevailed.

I can always practice a different kind of law. But for my clients, a ban on dangerous drug litigation leaves them with no recourse if they have been seriously harmed by a drug maker’s irresponsibility -- even if, as was alleged with Vioxx, the manufacturer knowingly exposed its customers to serious harm. Thanks to the Supreme Court, patients still have that option. If you or someone you love was seriously hurt by a defective prescription drug, The Lowe Law Firm can help. To set up a free consultation about your defective drug claim, please contact us through our Web site or call 1-877-678-3400.

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An over-the-counter weight-loss drug was recalled by the FDA due to serious safety risks, the Miami Herald reported Jan. 29. Venom Hyperdrive 3.0 was recalled after it tested positive in FDA laboratories for substantial amounts of sibutramine, a Schedule IV controlled substance not listed on the drug's label. The FDA is warning consumers to stop taking the drug immediately and contact their doctors for further medical instructions. They can also contact the manufacturer, Applied Lifescience Research Industries, at legal@alrindustries.com for instructions on returning the product for a refund.

As a controlled substance, sibutramine is illegal to dispense without a doctor's prescription. More importantly, the lack of warning makes the recalled supplement dangerous for people with heart disease, arrhythmia or a history of heart failure or stroke, because sibutramine increases blood pressure and heart rate. It's also contraindicated for people with several common conditions, including depression, eating disorders, a history of alcohol abuse or glaucoma. And it's not safe to mix sibutramine with certain other kinds of drugs, including opioid painkillers and a class of antidepressants called monoamine oxidase inhibitors.

This recall comes on the heels of a wider FDA recall of 69 weight-loss supplements that contain undeclared active ingredients, including drugs that are carcinogenic, controlled or not approved for use in the United States. Under these circumstances, selling a substance without telling consumers what it is may well be prosecuted as a crime. Even if it's not, this illegal and irresponsible behavior could kill many patients or cause them to develop serious or permanent health conditions. And that would expose manufacturers to hundreds or even thousands of drug injury lawsuits from people who have developed serious health conditions or lost a loved one to side effects of the supplements.

A defective drug lawsuit holds manufacturers legally responsible for their actions, but it also helps victims of unsafe prescription drugs recover some of the high financial costs of a sudden and serious health problem. An emergency room visit even for a minor problem can easily reach five figures; lifetime medical care for someone with a serious chronic condition can exceed the multi-million-dollar lifetime caps on health insurance plans. And of course, no price is high enough to compensate people who suddenly lose a loved one.

If you're facing these issues after you or someone you love took a defective prescription drug, the Lowe Law Firm can help. Our experienced defective prescription drug lawyers help people in Missouri and throughout the United States hold drug makers responsible for their carelessness. And we offer free consultations, so there's no risk in speaking to us about your case. To set up a free consultation today, contact the Lowe Law Firm online or call us at 1-877-678-3400.

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Because I'm a drug injury attorney in St. Louis, I have been following the news about KV Pharmaceuticals, a troubled St. Louis generic drug manufacturer. The most recent news, reported Jan. 26 by Fierce Pharma, is that KV has recalled all of the products that it manufactures itself, which is more than 100 drugs and the majority of its products. It's the fifth drug recall for KV Pharmaceuticals in a year, following closely after November and December recalls of specific products.

As I've blogged here before, the December recall was of oversized pills of hydromorphone, a morphine-related painkiller, which raised concerns about possible overdoses. In fact, the same oversized pill problem prompted all of the 2008 recalls, although different drugs (including morphine and dextroamphetamine) were involved. The company already faces lawsuits from patients, as well as lawsuits over corporate governance matters that led the company to replace its president and CEO in December. The article says KV is being investigated by both the FDA and the SEC.

The FDA has not yet announced the newest recall, although KV's press release suggests that it eventually will. The release does not specify why the company recalled its entire line of drugs, but given the serious financial problems KV is facing, they must have had a very good reason. And given the oversized pill problems it had throughout 2008, more manufacturing defects could be the culprit. While the drugs involved are different, any drug with an oversized pill presents a risk of an overdose, and an overdose of a powerful prescription drug is a serious matter. Depending on the drug, patients could risk death, heart attacks, hallucinations and other very serious side effects.

Patients who have suffered these effects after taking defective drugs from KV Pharmaceuticals -- or any other company -- have the right to hold the careless manufacturer legally responsible for the results. Based in St. Louis, the Lowe Law Firm handles these pharmaceutical liability cases for clients in Missouri and throughout the United States. To speak with our experienced defective drug lawyers at a free consultation, please contact us online or call 1-877-678-3400 today.

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A St. Louis-based drug maker has recalled some lots of generic Hydromorphone HCl and suspended shipments of other drugs because of manufacturing problems. According to an FDA press release, Ethex Corporation, a division of KV Pharmaceutical, recalled the painkiller Dec. 23 because the manufactured pills were larger than intended. This could cause an overdose of the drug, a morphine product with addiction potential and a federal Schedule II classification, leading to low blood pressure, breathing problems and sedation. People who think they might have the recalled drug (Lot #90219) should visit KV's Web site for more information on how to identify and return it.

This is the fourth recall by Ethex and KV over the last few months, according to an article by the St. Louis Post-Dispatch. Like this one, at least some of the past recalls involved oversized pills. At least two of them also involved morphine products that had the potential to addict patients or cause a fatal overdose. KV fired its longtime CEO for cause in December, has lost value on the stock market and doesn't expect to resume manufacturing its products until spring.

Morphine products are both useful and potentially dangerous because they are derived from opium. In addition to being highly addictive, they can slow the heartbeat and breathing, sometimes dangerously so. Oversized pills like the ones that were recalled could potentially give patients more of the drug than intended or marked on the packaging. In addition to raising the potential for a fatal overdose, this could also sedate patients more than intended, causing problems with driving or other everyday activities and raising the potential for a harmful drug interaction.

The article doesn't say how the corporate problems with this company may have affected its drug safety problems. But if a drug manufacturer or its decision-makers have suppressed important information about a drug's safety, the company is liable for a dangerous prescription drug lawsuit. In this case, that could mean multiple morphine overdose lawsuits filed by families who have lost a loved one to dangerously oversized pills. The Lowe Law Firm represents clients throughout the Midwest and the United States who have been seriously injured by a pharmaceutical company's failure to warn patients of their products' defects. If you or someone you love has been seriously hurt in this way and you’d like to learn more, please contact us online for a free evaluation of your case.

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The Lowe Law Firm has actively investigated cases of serious injuries and diseases stemming from the use of Zyprexa (olanzapine) in Missouri and throughout the United States. So we were pleased to see in the St. Louis Business Journal that Zyprexa's maker, Eli Lilly & Co., has agreed to an $800 million settlement with the U.S. Department of Justice over Zyprexa marketing practices. The settlement covers civil claims by federal and state Medicare and Medicaid agencies, as well as a $615 million fine for violating the federal Food, Drug and Cosmetic Act. Missouri's Medicaid agency will receive nearly $18 million as part of the settlement and Illinois will receive a combined $44 million for Medicaid and the state itself.

The claims stemmed from Eli Lilly's choice to market Zyprexa for off-label uses. The drug was approved by the FDA as an anti-psychotic for use with patients who have schizophrenia or bipolar disorder, but the company marketed it for a variety of maladies, including anxiety, age-related dementia and addiction to gambling. Marketing a drug for uses not approved by the FDA is illegal under the Food, Drug and Cosmetic Act. Unfortunately, Zyprexa has also been linked by research to serious blood-sugar and pancreas disorders, including diabetes, hypoglycemia and pancreatitis.

These are serious, chronic medical conditions that generally must be managed over the patient's entire lifetime. If they aren't detected and treated in time, they can lead to other serious medical problems, including diabetic comas, amputations and loss of eyesight. Just like other companies, drug makers like Eli Lilly have a responsibility to take reasonable care to avoid harming their customers. In this case, that could mean complete honesty about any information they may have had about Zyprexa and blood sugar disorders. It could also mean not encouraging primary care doctors to prescribe the medication for uses that weren't approved or intended by regulators.

When drug makers deliberately break laws and fail to warn the public about the risks of their products, they are legally liable for any harm they cause to their customers. In a defective drug lawsuit, consumers can win reimbursement for the cost of treating the side effects of dangerous medications; replace any income they lost; win compensation for the loss of their good health or a loved one; and ensure that the drug maker is forced to stop its deceptive and abusive practices. The Lowe Law Firm handles Zyprexa injury lawsuits and claims over many other defective prescription drugs, in Missouri and throughout the United States. If you believe you have a claim and would like to know more, please contact us today for a free consultation.

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PriCara, a division of Johnson & Johnson, has recalled two lots of Duragesic, a chronic pain medication delivered through the skin using an adhesive patch. According to financial news site RTT News, the patches may have tears in the area containing the active ingredient. This disables their time-release system for dispensing the drug, an opiate called fentanyl, which can lead to an overdose. Like other opiates, fentanyl has potentially fatal effects in an overdose, including breathing problems, seizures and slow heartbeat. Information about the recall is available on Duragesic's Web site.

This is the second Duragesic patch recall by PriCara within 12 months. The patches were last recalled on Feb. 12, 2008, because of similar problems with tears in the drug's reservoir. Another recall in 2004 led to at least three successful lawsuits filed by people whose loved ones died because of a Duragesic patch overdose. The FDA has not taken the drug off the market in the United States, but its Canadian equivalent, Health Canada, issued a warning Jan. 7 that patients may need to change their dosage of fentanyl to avoid an overdose.

Because I am a defective prescription drug lawsuit attorney, I know that overdoses are not uncommon with transdermal patches. In my pharmaceutical liability practice, I represent clients who have lost a loved one or had serious medical problems because of defective Ortho Evra patches. Ortho Evra is a form of birth control similar to the Pill, but it delivers about 60% more estrogen than pills, sharply increasing the number of women who developed dangerous blood clots as side effects. Johnson & Johnson has paid at least $68 million to settle Ortho Evra lawsuits, but the patch is still on the market.

A similar delivery malfunction with a potent opiate like fentanyl could easily kill hundreds of people who use Duragesic and other fentanyl patches regularly to manage chronic pain. If it does, and the manufacturing or design of the patch is to blame, Johnson & Johnson could be held legally responsible for the results -- physical, financial and emotional. If you or someone you love was seriously hurt by a malfunctioning patch or other prescription drug, The Lowe Law Firm can help. We offer free, confidential case evaluations to potential clients. If you believe you may have a claim and you would like to know more, please contact us today for a free consultation.

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A final report on the deadly contamination of the blood thinner heparin confirms that the problem was caused by a man-made chemical that was added to batches of the drug imported from China, The Washington Post recently reported.

The crisis, which began in November 2007, resulted in 152 adverse reactions and as many as 81 deaths in the United States. The Chinese heparin, contaminated with the chemical oversulfated chondroitin sulfate (OSCS), was found in at least 10 countries, according to federal officials.

Published in the December 18, 2008 issue of the New England Journal of Medicine, the report "describes the adverse reactions caused by the contaminant" and links it to a specific substance, Dr. Priti R. Patel, a medical epidemiologist with the U.S. Centers for Disease Control and Prevention, explained. The reactions included a drastic drop in blood pressure, nausea and shortness of breath, starting within 30 minutes after the administration of the heparin.

"There is a definite link between this contaminant and the patients who had these reactions," Dr. Patel said.

Continue reading "Heparin from China found to be contaminated with man-made chemical--defective drug attorney." »

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The U.S. Food and Drug Administration has warned consumers not to use any of 69 defective over-the-counter diet drugs, USA Today reported Jan. 7. The drugs covered by the warning have several active ingredients that are not listed on the labels, despite the fact that many are marketed as "natural" or "herbal" dietary supplements. The active ingredients include rimonabant, which failed to win FDA approval, and has been withdrawn from the market in Europe after authorities there linked it to five deaths and 720 adverse reactions. A full list of the affected drugs is available in the FDA's press release; consumers who have taken the drugs are urged to speak to doctors immediately.

Other unlisted but potentially dangerous active ingredients in the drugs include phenytoin, an anti-seizure medication; phenolphthalein, a suspected carcinogen; and sibutramine, a controlled substance related to the defective diet drug Fen-Phen. Sibutramine is approved for sale in the United States as Meridia, but has a wide variety of serious side effects, including high blood pressure, seizures, partial paralysis, breathing problems, serotonin toxicity and suicidal thoughts. Because of those side effects and potential drug interactions, it is not prescribed for people taking certain antidepressants and migraine medications, as well as those with heart and blood pressure problems, seizures, hyperthyroidism or certain psychiatric disorders.

By selling sibutramine, rimonabant and other potentially dangerous drugs without disclosing their ingredients, the manufacturers of these diet pills bypass the safeguards in our prescription drug system. This puts the drugs' users at risk of death or disabling chronic medical conditions -- when they thought they were taking harmless dietary supplements. The drug makers, most of which are located in China, may face criminal charges after an investigation. But for victims, criminal charges almost always come too late, after they've lost a loved one or suffered grave complications due to the defects in these "natural" supplements.

Treating a serious medical emergency can cost tens of thousands of dollars; a permanent chronic illness or disability can run into six or seven figures over a lifetime, not counting lost income for those who can no longer work. And these figures don't take into account the devastating personal losses suffered by victims and their families. To recover those costs and hold pharmaceutical companies responsible for their actions, many victims choose to bring defective drug lawsuits. The Lowe Law Firm has substantial experience with these dangerous medication claims. Based in St. Louis, we represent clients in Missouri, southern Illinois and throughout the United States. For a free consultation about your own claim, you can contact us online or call toll-free 1-877-678-3400.

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Levaquin, Cipro and other fluoroquinolone antibiotics continue to be over prescribed despite the risks of suffering the disabling side effects of tendinitis and tendon rupture.

This family of drugs includes Cipro (ciprofloxacin), Proquin (ciprofloxacin hydrochloride), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin (ofloxacin).

According to a recent article in the Atlanta Journal-Constitution, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics in 2007. Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and in patients given these antibiotics in conjunction with steroid therapy.

Some studies have concluded that the powerful drugs are often prescribed even when no antibiotic is needed or a safer antibiotic is more appropriate.

A study conducted by the University of Pennsylvania found that out of 100 patients prescribed fluoroquinolones, 81 received it for inappropriate conditions.

Last summer, the Food and Drug Administration told drug makers to add a black-box warning to fluoroquinolone antibiotics that come in pill and injectable form. Pharmacists are also required to provide an FDA-approved guide to patients who pick up prescriptions for this class of antibiotics.

The push to finally get out information is long overdue. Even some doctors don’t know about the dangers.

Dr. J.T. Cooper of Marietta, Georgia told the AJC that he didn’t know about the potential side effects when he began taking Levaquin for pneumonia. He suffered a near rupture of his Achilles tendon last September. Cooper was hospitalized for six days and lost two weeks of work. He has spent several weeks in a boot brace and won’t be able to resume driving until the end of the month.

Adverse reactions to prescription drugs cause more injuries and deaths in the United States than illegal drugs. If you have suffered medical complications from a prescription medicine or over-the-counter drug, an attorney with experience can advise you on your right to recover compensation for medical expenses, lost wages and pain and suffering.

For more information, fill out our online contact form or call 314-678-3400 or toll free 877-678-3400.

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Two different medications from the same manufacturer will get a “black box” warning from the FDA, the Washington Post reported Dec. 11. The FDA issued the warning for OsmoPrep and Visicol, drugs used to clear out the bowels before a colonoscopy, after discovering a strong association between the drugs and acute phosphate nephropathy (acute kidney damage). Both drugs are made of sodium phosphate by Salix Pharmaceuticals. The FDA has ordered the manufacturer to distribute materials informing patients of the problem and conduct a new clinical trial of the drugs.

According to an FDA doctor quoted in the article, the agency has received 20 reports of kidney injury associated with OsmoPrep, with an onset ranging from several hours to 21 days after use of the drug. The agency in 2006 warned patients with kidney problems to avoid the drugs, and has now added children, older patients and patients with certain health problems or taking certain medications to that list. Patients and their doctors can choose alternative drugs not containing sodium phosphate.

It is interesting to me, as a dangerous drug lawyer in Missouri and Southern Illinois, that this is the second warning in two years about this drug and acute kidney damage. The article doesn’t say whether or when Salix and the FDA knew that the high levels of phosphates in the drug could be harmful for everyone. But in general, pharmaceutical companies have a legal and ethical responsibility to disclose serious health risks of their drugs as soon as they know of them. All too often, they choose not to because of concerns about how bad PR could affect their profits.

When manufacturers place their profits over patient safety, they are legally liable for any deaths or injuries that result. Patients who are harmed in this way have the right to file a defective drugs lawsuit to recover their financial costs (including medical costs and time off work they wouldn’t have otherwise incurred), as well as compensation for a wrongful death or permanent disability.

At the Lowe Law Firm, our experienced dangerous drug lawyers have handled many such cases, including a large confidential settlement for six clients who suffered permanent heart damage from using diet drug Fen-Phen. If you or someone you love has been hurt by a drug whose dangers you believe were covered up and you’d like to discuss your case with us, please contact us for a free initial consultation. We offer house calls and hospital calls for potential clients who are not able to travel.

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Avastin one of the new generation of gentler cancer drugs according to a report published in the Journal of the American Medical Association called for a “black box” warning -- the FDA’s strongest, according to USA Today
-- the Nov. 18 report was an analysis of studies on the drug Avastin, which is approved for breast, colon and lung cancer patients.
In the new report, scientists found that about 12% of patients using Avastin developed potentially life-threatening blood clots, giving them a rate of blood clots that was 30% higher than the rate among cancer patients not using the drug. Blood clots can be dangerous because they can block blood flow completely, causing tissue death or a pulmonary embolism that cuts off the patient’s oxygen.

Blood clots are a common problem among cancer patients, according to the newspaper -- but evidence from this study shows that they are more common among cancer patients using Avastin. Because the clots are potentially life-threatening, the study’s authors called for an FDA “black box” warning about the risk for patients and their doctors. A spokesperson for Avastin’s maker, Genentech, demurred, pointing out that the FDA already runs a warning about the risk of blood clots on the drug’s label.

As a Missouri defective drug attorney, I hope patients take that warning seriously. In our prescription drugs practice at the Lowe Law Firm, we represent patients of all kinds who have been seriously hurt by prescription drugs that had serious dangerous side effects. In many cases, we have been able to prove that the manufacturer knew about the problem in advance but didn’t disclose it publicly -- sometimes, not until after an aggressive marketing campaign. This dishonest behavior betrays the patients and doctors who trust drug makers, and puts patients in serious danger.

At the Lowe Law Firm, we help victims of this dishonest behavior hold manufacturers legally liable for their actions. To speak with one of our experienced defective drug attorneys about your own case and your legal options, please contact us online or call us toll-free at 1-877-678-3400.

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A federal advisory panel concluded that two drugs, Serevent and Foradil, should be banned for use in the treatment of asthma, according to Reuters.

Studies have shown that when Serevent and Foradil are used without a steroid, the drugs can trigger more severe, life-threatening asthma attacks.

The panel of safety experts also recommended that two other asthma drugs, Advair and Symbicort, continue to be used on adults and children. However, the votes were far from unanimous on the question of use by children.

Advair is approved for children ages four and older. The advisory panel voted 13-11 with three abstentions to allow children in the youngest age group to use Advair.

Symbicort is approved for children ages 12 and older. The advisory panel voted 20-5 with two abstentions to allow children that age to use Symbicort.

The four asthma medications contain a drug known as long-acting beta agonist. The drug safety questions were raised after a study showed that Serevent could worsen asthma and even cause death, National Public Radio reports.

Adverse reactions to prescription drugs cause more injuries and deaths in the United States than illegal drugs. If you have suffered medical complications from a prescription medicine or over-the-counter drug, an attorney with experience can advise you on your right to recover compensation for medical expenses, lost wages and pain and suffering.

For more information, fill out our online contact form or call 314-678-3400 or toll free 877-678-3400.

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A study released on Dec. 2 confirms what many previous studies have already found: Patients given the anti-bleeding drug Trasylol have a higher risk of dying than those who receive less expensive clotting drugs.

Canadian and Australian researchers reviewed findings from 49 randomized clinical trials. While Trasylol (aprotinin) was found to be more effective at controlling blood loss than lysine analogues, the higher fatality rate associated with the drug as well as its expense outweighed the benefits.

Dr. David Henry, one of the co-authors of the study which will be published in the Jan. 20 issue of the Canadian Medical Association Journal, concluded:

"Lysine analogues are almost as effective as aprotinin in controlling blood loss, are cheaper, and appear not to increase mortality."

Since 2006, several studies have linked Trasylol to an increased risk for kidney damage, stroke and death. If Bayer, the maker of Trasylol, had removed the drug from the market when it learned of the health dangers, it is estimated that 22,000 lives could have been saved.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

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The Journal of the American Medical Association reported last week that it found that artificial blood raised the risk of death by 30 percent and tripled the chances of suffering a heart attack.

The researchers reviewed data collected from sixteen clinical trials and concluded that the dangers were so great that the U.S. Food and Drug Administration should have halted the studies eight years ago.

Because the FDA received the data in 2000, the researchers argued that the agency should have stopped the human trials until a large-scale analysis could be completed. The researchers also blasted a rule that forced the FDA to keep new product information confidential.

In an interview with Bloomberg News, Charles Natanson, one of the study’s authors and a septic shock researcher at the National Institute of Health, said,

“If you have secret science, things like this can happen. Once you’ve randomized patients, your results can’t be a trade secret. It’s a measure of protection to the American public.”

The companies at the center of the blood substitute study include Baxter International Inc., Biopure Corp., Hemosol BioPharma Inc., Northfield Laboratories Inc., and Sangart Inc.

Because actual blood must be refrigerated, has a shelf-life of just over 40 days, carries a disease transmission risk, and may only be used with compatible blood types, pharmaceutical companies have been working on a blood substitute.

Sidney Wolfe, one of the study’s authors and the director of the Washington-based advocacy group Public Citizen, Inc., told Bloomberg News that none of the original trial results were published immediately and the FDA reviewed each study separately.

Wolfe said:

“When we talk about things that make it more likely people will be harmed or killed, and you keep it a trade secret, it's inexcusable.”

Once again, the pursuit of profits by drug companies was left unchecked by an impotent FDA. As was the case with Trasylol, Vioxx, and Avandia, the patient is the one who pays the price.

The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous prescriptions drugs and medical devices. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

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Bayer is finally removing the remaining supplies of Trasylol from the U.S. market after a long-awaited Canadian study confirmed yet again that the anti-bleeding drug is dangerous.

On May 14, the BART study was published in the New England Journal of Medicine. Researchers found that heart surgery patients who were given Trasylol were 53 percent more likely to die than patients who were given cheaper blood clotting drugs.

That same day, Bayer notified the U.S. Food and Drug Administration that it will begin removing remaining Trasylol stock from the American market, most of which can be found in warehouses and with doctors and hospitals.

This should have been done a long time ago. Since 2006, three studies have linked Trasylol to an increased risk for kidney damage, stroke and death. If Bayer had removed the drug from the market when it learned of the health dangers, it is estimated that 22,000 lives could have been saved.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

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The results of the long-awaited Canadian study on the anti-bleeding drug Trasylol were announced today in the New England Journal of Medicine.

Researchers found that patients who were given Trasylol, known generically as aprotinin, had a 53 percent higher death rate than patients who were given comparable drugs.

In an editorial that accompanied the BART study, Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University wrote:

“Thus, in all likelihood, this is the end of the aprotinin story.”

Trasylol is made by Bayer. On Jan. 20, 2006, an article suggesting a link between Trasylol and renal toxicity was published in the medical journal Transfusion. Later that same month, the New England Journal of Medicine published an article, co-authored by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, linking Trasylol to a higher risk of stroke, heart attack and kidney failure.

In the fall of 2006, an FDA advisory board met to decide whether the warning on Trasylol needed to be changed. At the meeting, Bayer failed to disclose the findings of a Trasylol study it had funded. In that study, Dr. Alexander Walker—a professor at the Harvard School of Public Health—reviewed the hospital records of 67,000 patients and found that those given Trasylol had a risk of death 64 percent higher than that of patients who received a comparison drug. It wasn’t until November 2007 that the drug was finally pulled from the market.

The BART study is significant because it was designed as a side-by-side comparison of aprotinin with two other drugs, tranexamic acid sold under the brand name Cyklokapron and aminocaproic acid, sold under the brand name Amicar.

Not only are the comparison drugs safer, they’re much cheaper. According to an article in Reuters, a Trasylol treatment costs between $1,200 and $1,500. The other two drugs cost about $150.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

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The Food and Drug Administration’s top staff regulators were against shielding drug makers from lawsuits, the Los Angeles Times reports.

Internal documents released by Rep. Henry A. Waxman (D-Beverly Hills) reveals that top FDA regulators did not trust pharmaceutical companies to warn patients of new risks associated with prescription drugs. However, Bush Administration appointees argued that, under the legal doctrine known as preemption, the FDA process approving drug labels should be sufficient to shield drug makers from consumer lawsuits.

But the FDA’s own experts on the drug approval process disagreed.

Dr. John Jenkins, director of the Office of New Drugs, wrote in a 2003 memo:

"The premise of the basis for much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real-time basis. We know that such an assumption is false."

As the LA Times’ reporter David Savage points out, the FDA has regulated new drugs for more than 100 years. At the same time, the FDA did not attempt to block lawsuits filed against drug makers by patients who were hurt by dangerous drugs.

Now that right is at stake. In a case before the U.S. Supreme Court, Wyeth is asking the Court to shield it from a lawsuit filed by a musician who lost her arm as a result of gangrene caused by an anti-nausea drug.

Like the experienced staff regulators at the FDA, attorneys who represent victims who have been harmed by dangerous drugs understand that drug makers are not eager to disclose all the risks associated with their medicines. Lawsuits play a vital role in protecting the American consumer.

My law firm currently represents victims and their families in lawsuits against most of the major drug companies including Merck, Pfizer, Bayer, Eli Lilly and others. The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous prescription drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

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A woman who claimed diet drugs caused her lung-destroying disease has been awarded $3 million by a New Jersey jury, Bloomberg News reports.

The verdict against Wyeth, the maker of Pondimin, was handed down on Oct. 22. The plaintiff, Gloria Stribling filed suit in Bergen County Superior Court after she was diagnosed with primary pulmonary hypertension, an often-fatal illness.

Pondimin and another Wyeth-made drug, Redux, were often combined with phentermine to form the appetite suppressant fen-phen. More than six million people were described the diet-drug cocktail before Wyeth pulled the drugs from the market in 1997 after researchers linked the treatment to heart damage and PPH.

Stribling took the fen-phen combination from November 1995 to October 1996. She was diagnosed with PPH a decade later. The trial against Wyeth began on Sept. 3. The jury concluded that Pondimin was a “substantial contributing factor” in causing the lung disease.

Wyeth, which has set aside $21 billion to cover costs associated with fen-phen litigation, is reviewing post-trial options.

It is now well-established that new cases of PPH caused by the diet drugs are now being diagnosed for the first time. This is because there may be a latency of 10-20 years after cessation of the diet drugs before the PPH disease occurs.

The Lowe Law Firm has tried and or resolved Fen-Phen opt-out cases . We are dedicated to obtaining compensation for people who have this disease through the negligence or deceit of drug companies. Although drug company executives were warned of the dangers of these drugs and knew of many cases of Fen-Phen-related PPH, they hid this information from the public.

If you believe that you or a loved one has contracted PPH from using Fen-Phen, contact The Lowe Law Firm today. We can help you obtain the compensation you're entitled to by law.

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Pfizer Inc. has agreed to pay $894 million to settle personal injury and consumer fraud claims involving pain medications Bextra and Celebrex.

The announcement, made on Oct. 17 by New York-based Pfizer, will settle about 90 percent of the lawsuits filed against the drug maker over the COX-2 inhibitor. The Cox-2 family of drugs is suspected of increasing heart attacks.

In 2005, the Food and Drug Administration asked Pfizer to remove Bextra from the market. It has been associated with Stevens-Johnson syndrome and toxic epidermal necrolysis, a pair of rare and potentially deadly skin diseases.

Celebrex is still on the market despite claims that it patients risk blood clots, heart attacks, strokes and other cardiovascular problems if they use the drug.

From the settlement, about $745 million will be used to resolve the personal injury lawsuits. Approximately $60 million will be used to settle claims brought by 33 states and the District of Columbia alleging that Bextra was inappropriately marketed. Another $89 million will be used to settled consumer fraud cases.

My law firm currently represents Bextra and Celebrex victims and their families in lawsuits. The lawyers of The Lowe Law Firm are experienced in helping people injured by defective and dangerous drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

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Last month, the preliminary results of a German study were released that suggest stroke patients who take certain anti-anemia drugs increase their chances of dying.

The U.S. Food and Drug Administration warned on Sept. 26 that a clinical trial investigating the use of high doses of epoetin alfa to treat acute ischemic stroke found that patients who received the drugs died nearly twice as often as the patients who received the placebo. Sixteen percent of patients who received the anti-anemia drugs died. Patients who received a placebo had a nine percent death rate.

According to the U.S. News & World Report, epoetin alfa is used in drugs such as Aransep, Procrit and Epogen. Although the drugs are on the U.S. market, they have not been approved for use in stroke recovery.

This past July, the FDA required the makers of Aransep and Procrit warning that the drugs can cause cancer tumors to spread and raise the risk of bleeding. Although an FDA advisory committee recommended keeping the drugs on the market, the committee urged that they not be used in people with curable cancer.

In its most recent safety warning, the FDA indicated it will be reviewing additional data over the course of several weeks. Once the review is complete, the FDA will issue conclusions and recommendations.

The Lowe Law Firm offers a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

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On Nov. 3, the U.S. Supreme Court will hear oral arguments in an important case which could threaten the rights of consumers to sue drug makers over dangerous prescription medicines.

In 2000, musician Diana Levine went to the hospital complaining of nausea associated with a migraine headache. Doctors injected the anti-nausea drug Phenergan, which is made by Wyeth, into her muscles. When the medicine failed to rid Levine of her nausea, her physicians decided to administer the drug a second time. Instead of using an IV drip, her doctors gave her the drug by using an “IV push” method in which the medicine is delivered directly into the vein. The drug made contact with her arteries causing gangrene. Her arm had to be amputated as a result.

Levine sued Wyeth in Vermont state court alleging that the drug company failed to warn of the risks associated with an IV push of Phenergan.

The Phenergan label had been approved by the Food and Drug Administration in 1955 and re-approved in the 1980s. Although Wyeth knew that the anti-nausea drug could cause gangrene if it reached the arteries, it did not mention the dangers associated with the IV push method. In addition, there was no evidence that the FDA ever considered whether the label should have contained such a warning.

The jury sided with Levine and awarded her $6.7 million. Wyeth appealed, arguing that the FDA approval process overrides state tort law. The Virginia Supreme Court disagreed, concluding that nothing in federal law prevented Wyeth from providing additional warnings.

On Jan. 18, the U.S. Supreme Court agreed to take the case, Wyeth v. Levine, to consider the preemption issue.

The stakes are high. Friend of the court briefs urging the Court to adopt Wyeth’s position have been filed by pharmaceutical groups, the U.S. Chamber of Commerce and the Bush administration. Amicus briefs urging the Court to uphold the jury award have been filed by a number of consumer groups.

My law firm currently represents victims and their families in lawsuits against most of the major drug companies including Merck, Pfizer, Bayer, Eli Lilly and others. The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous prescription drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases. This legal argument of preemption is the result of an expansion of power by the Bush Administration. Hopefully the Supreme Court will not decide in favor of this unjustified protectionism of drug companies.

My prediction is that there will be limited preemption but not total preemption. Based on the facts of the case the Supreme Court took I think they will hold in a 5-4 decision that if the drug company provided all of the required information to the FDA and the FDA considered it, that an injured person will not be able to claim that the warning is inadequate. We will just have to wait until January 2009 to see. Also if they completely preempt prescription drug cases it looks like there will be a democratically controlled House, Senate, and Presidency, and they can write new legislation overturning the Supreme Courts ruling.

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According to an announcement made by the U.S. Food and Drug Administration, Bayer’s clotting drug Trasylol will now only be available for investigational use.

To use Trasylol, a doctor must conclude that a heart surgery patient has a high risk for blood loss, no other medication will work and that the “benefits of the drug clearly outweighs the risks.”

The news was part of a May 14 statement in which the FDA also indicated that Bayer had agreed to pull the remaining stocks of Trasylol from the U.S. market.

Earlier that same day, the Bart study was published in the New England Journal of Medicine. The study concluded that heart surgery patients given Trasylol had a 53 percent higher chance of dying than patients given less expensive, comparable drugs.

Since 2006, three studies have linked Trasylol, also known as aprotinin, to an increased risk for kidney damage, stroke and death.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

Posted by Carey, Danis & Lowe | Permalink | Email This Post

Posted In: Dangerous Drugs

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According to an announcement made by the U.S. Food and Drug Administration, Bayer’s clotting drug Trasylol will now only be available for investigational use.

To use Trasylol, a doctor must conclude that a heart surgery patient has a high risk for blood loss, no other medication will work and that the “benefits of the drug clearly outweighs the risks.”

The news was part of a May 14 statement in which the FDA also indicated that Bayer had agreed to pull the remaining stocks of Trasylol from the U.S. market.

Earlier that same day, the Bart study was published in the New England Journal of Medicine. The study concluded that heart surgery patients given Trasylol had a 53 percent higher chance of dying than patients given less expensive, comparable drugs.

Since 2006, three studies have linked Trasylol, also known as aprotinin, to an increased risk for kidney damage, stroke and death.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

Posted by Carey, Danis & Lowe | Permalink | Email This Post

Posted In: Dangerous Drugs

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