Last week, the Food and Drug Administration (FDA) requested that drug manufacturer Abbott Laboratories strengthen the product labeling for its weight-loss drug Meridia (sibutramine) to disclose an increased risk of heart attack and stroke in patients with a history of cardiovascular disease.
The FDA’s request comes on the heels of its review of additional data from the SCOUT (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event) trial, which was a six year study including approximately 10,000 overweight and obese patients with a history of heart disease, diabetes, or both. According to the FDA’s safety alert, the study was intended to investigate whether treatment with Meridia was more effective than placebo in reducing the risk of cardiovascular events.
Early results from the SCOUT trial, released in November 2009 and reviewed by the FDA at the time, showed that Meridia actually increased the risk of heart events, and last week’s update confirmed that this increased risk was specific to patients in the study with a history of cardiovascular disease.
Interestingly, the FDA’s European counterpart, the European Medicines Agency (EMA), took a different tack. The EMA advised physicians to stop prescribing Meridia altogether.
If you or a family member has a cardiovascular event while taking Meridia, you can contact our firm to help you determine whether you have a legal claim. Call us at (610) 941-4204 or reach us on the web at www.pbmattorneys.com. We are here to listen to your story, and we’ll help you protect your legal rights.