Drug Injury Attorney Blog

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 " »

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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