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.
Based in St. Louis and Belleville, Ill., the Lowe Law Firm represents clients who were seriously harmed by proper use of a medication or medical device. As this issue shows, FDA approval alone is not enough to guarantee a drug’s safety. Like all manufacturers of consumer products, drug manufacturers have a duty to warn their customers if there is a serious risk from taking the drug, regardless of how the FDA chose to handle the issue. Our defective drug lawyers help patients who are harmed by a manufacturer’s failure to live up to that duty — its failure to warn the public about safety risks. In a lawsuit, patients can recover the often substantial long-term costs of treating a health problem caused by a defective drug. They can also collect compensation for their illness or injury, pain, suffering and any permanent disability or wrongful death.
If your family has suffered a serious injury because of a defective prescription or over-the-counter drug, you should call the Lowe Law Firm for help. To set up a free, confidential consultation, you can reach us through our Web site or call 1-877-678-3400 today.