Drug Injury Attorney Blog

Gianvi, a repackaged and renamed generic version of Bayer's flagship contraceptive Yaz, is under scrutiny after its parent company admitted to inappropriate labeling practices.

According to Bayer, the company marketing Gianvi has admitted that it falsely labeled the generic medication. For example, it claimed that the medicine contained Bayer's “technology” that extends shelf life. Let's lay aside the fact that a chemical pill cannot contain “technology,” only combinations of chemicals. This is more than a simple mix up; it means there's a drastic difference between the perceived shelf life of the medicine and the actual shelf life. This means more costs to be spent informing people of the problem, with no word on exactly how the information will be spread out to consumers.

Think about the recalls and information campaigns you've encountered lately. How many of them took the form of a genuine, informative commercial during prime time television or radio hours, where a large audience could hear about them? Now, how many do you recall that took the form of a small, badly-positioned flyer at the local drugstore?

This amounts to a further complication in the complicated generic question. Gianvi has the same risks of heart disease, blood clot and stroke that Yaz and Yasmin carry, yet it's marketed and advertised under a different name. Now the medicine is subject to a relabeling that focuses on the packaging, without further addressing the information that this drug has been linked to a number of cases, ranging from middle-class women to Broadway stars, of serious health complications. It results in a further muddying of the waters and a lack of quality control, all stemming from the rapid proliferation of the original medication in generic forms.

Yaz, Yasmin and Gianvi, despite the established risks and dangers taking them compared to earlier-generation progestins, continue to be some of the biggest sellers for Bayer and the generic manufacturer Teva Pharmaceuticals.

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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 " »

A Louisiana couple has filed a lawsuit alleging that the anti-nausea medicine Reglan caused their child to suffer birth defects after the mother was prescribed it during her pregnancy. While Reglan normally is associated with the movement disorder Tardive Dyskinesia, the full range of its side effects has not necessarily been explored.

The complaint, which began in state court but has since been transferred to federal court, states that Lindsey Whitener was prescribed the anti-nausea medication to help her cope with morning sickness that had persisted into her seventh week of pregnancy. The first trimester of a pregnancy is a critical time in the development of the child, making it a contentious period regarding the prescription of any strong medications. Their son, Lucas, was born with so many health problems and complications that he was hospitalized for a full six months after being born. He further suffers from permanent disability that his parents blame on the Reglan prescription.

As mentioned, this case is unusual in that it departs from the normal pattern of Reglan cases. However, the Whiteners claim that they have shown their case to a number of physicians since discovering Lucas' illness, and none has been able to rule out the involvement of Reglan in their son's birth defects. As such, they wish to have their day in court and demand answers from multiple sources.

The case is wide-ranging in its choice of defendants, as well. It targets the companies Pliva Pharmaceuticals, Barr Laboratories, Teva Pharmaceuticals and Watson Pharmaceuticals — all are generic manufacturers of Reglan. The suit also names the Rue de Sante Women's Medical Center and John McCrossen, presumably the hospital and doctor involved in prescribing the medication to Mrs. Whitener.

Last year, a federal judge ruled that the many Reglan cases currently pending would not be consolidated into a larger lawsuit, but would rather need to proceed individually. As such, the Whitener case will have to be presented in its own separate venue, and bears watching.

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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.

There have been a number of issues raised about the safety of the popular antidepressant Paxil. It has been linked to increased suicide risk in young children it is prescribed to, as well as a number of birth defects. A definitive causal relationship may not have been demonstrated, but warning flags have been going up consistently since its approval by the FDA.

Part of the skepticism that surrounds Paxil and related antidepressants is the huge amount of good press the producers — in this case Glaxo Smith Kline (GSK) — give themselves, while downplaying their negative effects. The object isn't necessarily even to force GSK to close down, or to take Paxil entirely out of the market, but to rather demand honesty in advertising and a much more stringent set of guidelines as to who and who cannot be prescribed the medicine.

When GSK is busily promoting the drug, however, information can be difficult to sift through.

For example, consider the growing concerns about Study 329, an investigation GSK did into its antidepressant. The spin put on the article basically suggested that the results were positive and favorable. However, ongoing investigations have raised doubts about the accuracy of these claims.

Reports from 1998 indicate, for example, that GSK was aware the actual results of the study were negative, rather than positive. Attempts to investigate and call these matters into question were met with hostility. Furthermore, there is evidence that the entire article was ghostwritten. Ghostwriting (the method of hiring a professional writer to write the actual documents) is a valid practice in many cases, but one wonders why the research team didn't have anyone qualified to write up and publish their works.

GSK eventually had to admit that they had overstated the positive effects of its big name medication. In many ways, this story highlights the core difficulty of dealing with such companies. They can massage data and have in-house teams perform dubious evaluations, while investigations from outside are difficult and take expert hands.

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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."

When discussing the impact of medications such as Levaquin, there are a number of ways to present the information. The stories we hear first and most often tend to be the ones that imbed themselves in our consciousness. On the other hand, the first reaction we hear about doesn't always tell the whole story.

Levaquin has been linked with the development of tendon injuries ranging from mild to crippling. There are cases such as that of an 88-year-old gentleman who was prescribed the medication, and within two weeks developed excruciatingly painful deformities in the tendons in his ankles, requiring several months of rehabilitation but resulting thankfully in a complete recovery with no signs of further complication.

However, there are also other cases where recovery hasn't been so quick, or so complete. Some of these injuries are very serious, and depending on the rate at which patients recover could take years to fully correct. Others are even crippling, unable to be entirely repaired due to the nature of the burst.

Even more sobering are the possibilities of other side effects. Consider a leg injury caused by a burst tendon, requiring immobilization if the patient is not a good surgical candidate. This could require extended periods of lying in one place, increasing the possibility of peripheral artery disease, where blood clots form in the extremities due to poor posture and reduced muscle movement. Medications used to treat the injury could have their own side effects — some people respond well to anti-inflammatory medications, others do not. This makes managing the pain and swelling that may be present in a tendon rupture a tricky proposition.

The most common type of rupture is, of course, the Achilles tendon tear. A great deal of weight is put on this tendon during the day and the course of our lives, and thus it presents frequently in Levaquin cases. This kind of injury frequently does require immobilization and physical therapy and often is difficult to correct surgically.

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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 " »

Getting the word out about the effects that Yaz and Yasmin have on worsening blood clots in their users is difficult. One of the hardest parts of trying to gain compensation for damages caused by medications is the lack of a voice in many of the patients. Most aren't people with many ties, or some kind of political muscle. Most are quiet, ordinary people who don't want to sue anyone and who haven't the slightest clue how to get the word out. In these cases, it can be a relief to have a champion, someone with a high profile who is willing to carry the standard. In the case of Yaz, such star power has finally arrived.

Broadway actress Brenda Hamilton, an understudy in the long-lived and popular play Wicked, has filed a lawsuit against Bayer. In short, her suit claims that taking Yaz lead directly to a stroke she suffered in May of 2007. Furthermore, she alleges that Bayer knew that older-generation medications were both sufficient and safer than Yaz, but withheld information about it from both patients and doctors while aggressively advertising its new medications.

“I’m pretty angry that this happened to me,” Hamilton said in an interview. “I was 27 at the time. I don’t think this should be happening to young women. It shouldn’t happen to any woman just because they take birth-control pills.”

She said that she had no prior history of serious health problems when she had the stroke, and described the experience as terrifying.

There is a great deal of merit to Hamilton’s case. Even though Bayer, of course, defends its product, there are currently some 1,100 cases in the United States and Canada that have been filed against the company regarding these medications. The FDA has warned Bayer in the past for downplaying the safety issues with these two medicines, as well. Perhaps Hamilton’s popularity and name will help bring this case more into the light, where people can find the resolution they’re seeking.

More and more women are reporting negative side effects as a result of taking the popular, aggressively-marketed contraceptive hormone Yaz and its sibling medication Yasmin. Studies in Europe and America alike have shown a consistent link between taking these medicines and experiencing thickened blood, resulting in increased clotting and cardiovascular risks. One such risk is having either an ischemic or hemorrhagic stroke.

An ischemic stroke is death in brain tissue caused by an interruption in the blood supply. Such interruptions are frequently a result of arteries that have been clogged with blood clots. A hemorrhagic stroke results when the blood vessels in the brain burst, leading to bleeding between the brain and the skull, or between brain hemispheres.

Ischemic strokes are the less dangerous of the two, but are still deadly serious. Symptoms include varying degrees and durations of paralysis, a loss of coordination, numbness in one or more parts of the body, confusion or dizziness and difficulty speaking clearly. There is the potential for long-term damage depending on the duration of the blockage and how much damage has grown in the period between the stroke and treatment. Approximately one in three patients go on from an ischemic stroke to regain full function of his body.

Hemorrhagic strokes are incredibly dangerous. They can and do result in death if left untreated, so any medication like Yaz must be treated and prescribed with respect when such an occurrence is a risk. They are often signaled by a sudden, severe headache. Symptoms spread rapidly from the onset of the headache, and often appear very similar to those of an ischemic stroke: partial paralysis, confusion and trouble speaking and moving.

In either case, rapid medical treatment is the key to surviving and mitigating the damage caused by a stroke. However, this is only the first part of the story. Recovering from a stroke can be a long, expensive process. Access to medical care is universally expensive, and rehabilitative therapy requires a degree of investment that can be difficult to endure.

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 " »

The FDA is an important part of the American medical landscape. As a regulatory body, it is tasked with making sure that pharma companies don't cut corners or engage in dangerous practices. So it's natural that the FDA has been keeping an eye on the developing worries associated with the birth control medicines Yaz and Yasmin. By this point in time, information about the potential health risks of these medicines is available, thanks to such efforts. However, the information available is not necessarily complete, and a fresh look usually is beneficial.

For example, did you know that the history of difficulties with Yaz and Yasmin goes back to a warning issued by the FDA in 2003? The drug first was approved in 2001. Two years later and there were already warnings being issued to Bayer for misleading business practices. Specifically, FDA officials warned Bayer for overstating the safety of its new medications. Bear in mind, this is not a narrowly-prescribed medicine — Yaz is approved for the treatment of acne. A medicine that can cause blood clots and even strokes has been promoted as perfectly safe for treating young ladies for acne. A further warning was leveled for the same problem in 2008 as well.

Of course, language is everything. Saying that a warning was given can mean a number of things, after all. If we're pulled over and given a warning, nothing happens to our bank accounts or licenses. In Bayer's case, the 2008 warning resulted in a $20 million dollar fine. The company was ordered to use the money to pay for an advertising campaign to serve as a correction for misleading advertisements stating how safe Yaz was. $20 million dollars is more than some government programs have in their budgets at any given time. Yet people aren't always aware of this information, which makes getting the word out to everyone possible a priority for anyone concerned with the effects these medicines may have on their friends and loved ones.

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Cymbalta is one of the most popular and most advertised SSNRI antidepressants. It’s an attractive drug, as it can be used to treat both severe depressive disorders and pain caused from nerve damage related to diabetes. Nerve damage is incredibly and persistently painful, and thus any medication helping treat it is often embraced with exceptional happiness. The problem is, like many SSRI and SSNRI medications, it has been linked to serious birth defects when exposed to children in the womb.

The most common defects are cardio-respiratory ones — those affecting the heart and lungs. Heart defects such as holes between heart chambers are common. A recurring disorder is PPHN, or persistent pulmonary hypertension of the newborn. PPHN is a condition in which a newborn infant cannot properly adapt to breathing without the assistance of the mother's umbilical cord. Once outside the womb, breathing becomes difficult, painful and inefficient. It is not uncommon for patients with PPHN to require serious operations and lung transplants.

However, these are simply the disorders that affect the child's body. In other cases, the child might not even make it to birth. In one study, approximately a third of women who took antidepressants in Cymbalta's class experienced severe birthing complications. The might miscarry or give birth prematurely, the child might be born on time but underweight, or in some terrifying cases the children developed seizures.

Approximately 20 percent of women who take SSRIs and SSNRIs ended up giving birth prematurely, compared to 12 percent in those mothers who did not take the medicines. When mothers took the meds, fetal death more than doubled compared to mothers who did not expose their children. PPHN incidences increased between three and six times in frequency among infants who were exposed to SSRI or SSNRI medications while their mothers were pregnant, particularly during the first trimester.

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 " »

The link between antidepressants and birth defects has been a point of hot contention for some time now. SSRIs and SSNRIs ranging from the obscure to the highly popular and iconic have been linked to a number of conditions such as clubbed feet, heart defects, exposed internal organs and even premature death in the womb. Some advocates insist these numbers are low, but other studies indicate that the incidence of events has doubled, which is a staggering increase.

Regardless of which side of the frequency fence you sit on, the fact that there is the potential for a problem is indisputable. Recent evidence suggests that it may get worse before it gets better.

According to news agency Reuters, a study of 1,500 U.S. citizens diagnosed with depression showed that a staggering 80 percent of them preferred treatment with antidepressants to talking therapy with a counselor. The most common drugs of choice were older generation SSRIs such as Prozac, which is one of the drugs linked to the formation of persistent pulmonary hypertension of the newborn (PPHN) in infants whose mothers took the medicine during pregnancy.

Interestingly, the study also looked at the efficacy of treatment. It showed that for those patients that did seek out talking therapy and counseling as opposed to medication, recovery rates were very similar to those who chose an SSRI. This is sobering news, because it implies there is some kind of disproportionate representation somehow. For some reason, Americans prefer medication. This could be because of advertisements of the pills on television, or a culture that is becoming more accepting of those who require medical treatment for legitimate mood disorders. Whatever the reason, 80 percent isn't simply a majority — it’s an overwhelming majority. If the trend continues, it is clear that there is going to have to be some kind of campaign to make sure mothers prescribed these medicines are informed of their options and the risks involved.

As we’ve discussed, there are many drugs in the SSRI and SSNRI class that can result in serious birth defects should fetuses be exposed to them. These defects range from vascular and respiratory disorders to outright deformations such as clubbed feet and misshapen skulls in the children. Any of these conditions is frightening and heartbreaking for a parent.

Lexapro is an SSRI, and as with most such drugs is used to treat several problems. In this case, it treats both depression and anxiety disorders. This means that it is more likely to be widely used than a single-target drug, especially because these two conditions are known to overlap. More use means more potential for exposure, and with few to no studies available showing that the medicine is safe to use in pregnant women, the picture becomes rather dire.

Persistent Pulmonary Hypertension of the Newborn (PPHN) has been discussed, but it is important to fully understand how it works and what effects it has on the children forced to cope with it. In PPHN, the arteries in the lungs are consistently being squeezed. This restricts the amount of blood that can move through these vessels, which increases blood pressure. As blood pressure increases, blood is unable to spend as much time in the lungs, and the rate of oxygen renewal drops. This makes it hard to breathe or catch your breath. Imagine how difficult it is when you can't breathe, and then extend that to an infant that can't understand what's wrong, and you have a picture of the terror this can cause.

When exposed to SSRIs like Lexapro, a group of 1,000 infants will have approximately six to 12 who exhibit signs of mild to severe PPHN. The usual incidence of infants exhibiting this condition without such exposure is approximately one or two per 1,000. This severe increase is disturbing evidence that doctors must begin exhibiting extreme caution when prescribing Lexapro to pregnant women.