Drug Injury Attorney Blog

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.

Continue reading "Senate Investigation of Avandia Shows Manufacturer Knew About Risks Years Ago" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Study Shows Common Antidepressant Lowers Effectiveness of Breast Cancer Drug" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "FDA Issues Stronger Warning About Metabolic Problems for Teens Taking Zyprexa" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Study Shows Anti Obesity Drug Raises Risk of Heart Attack or Stroke in Heart Patients" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "FDA Expands McNeil OTC Drug Recall, Rebukes Manufacturer for Yearlong Delay" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Reports Find Nursing Homes Use Antipsychotics Off-Label Despite Safety Warnings" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Analysis Finds Antidepressants Have Little or No Benefit for Mild Depression" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "FDA Requests Further Studies of Diabetes Drug Due to Reports of Pancreatitis " »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "FDA Updates Antidepressant Warning Label to Include Risk of Sudden Cardiac Death" »

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

Posted In: Dangerous Drugs

Bookmark:

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" »

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

Posted In: Dangerous Drugs

Bookmark:

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" »

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

Posted In: Dangerous Drugs

Bookmark:

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" »

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

Posted In: Dangerous Drugs , Dangerous Medical Devices

Bookmark:

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.

Continue reading "Study Confirms Serious Blood Clot Threat From Anemia Drugs for Cancer Patients" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Diabetes Drug Prescribing Information Revised to Reflect Reports of Kidney Problems" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "European Regulators Review Arthritis Drug Safety as FDA Announces New Case of Brain Infection" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "FDA Orders Black Box Warning for Injected Sedative at Center of Supreme Court Case" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Memo Introduced at Paxil Trial Suggests Drug Company May Have Buried Negative Studies" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Scientists Question Findings in Study of Asthma Drugs Funded by Drug Manufacturer" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Manufacturer Recalls Generic Adderall Because of Oversized Pills Posing Risk of Heart Problems" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "FDA Reviewing Data Suggesting Asthma Medication May Cause Heart Problems and Strokes" »

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

Posted In: Dangerous Drugs

Bookmark:

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" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "FDA Requires Black Box Warning for Label of Gastrointestinal Drug Reglan" »

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

Posted In: Dangerous Drugs

Bookmark:

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" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

Continue reading "Anti-Smoking Drugs Chantix and Zyban Get Black Box Warning About Risk of Suicide and Mental Illness" »

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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." »

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark:

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.

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

Posted In: Dangerous Drugs

Bookmark: