At the request of the Food and Drug Administration, Abbott Laboratories announced today that it is withdrawing the obesity drug Meridia (sibutramine) from the market, because studies now show that the drug significantly increases the risk of serious cardiovascular events.
The FDA made this request on the basis of the results of the SCOUT trial, which randomized 10,000 overweight patients to either receive Meridia or placebo. After an average of 3.5 years, those taking Meridia had a 16% increased incidence of cardiovascular events (primarily non-fatal heart attacks and non-fatal strokes). John Jenkins MD, director of the Office of New Drugs at the FDA said, "Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke."
Doctors should no longer prescribe Meridia. If you are taking this drug, you should contact your doctor for instructions.
Furthermore, the FDA simultaneously issued a consumer warning that the over-the-counter product Slimming Beauty Bitter Orange Slimming Capsules also contains sibutramine, even though sibutramine does not appear on the product label. The FDA recommends that consumers stop taking this product immediately.
Sources:
Food and Drug Administration. Abbott Laboratories agrees to withdraw its obesity drug Meridia [press release]. October 8, 2010. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm228812.htm
Food and Drug Administration. Slimming Beauty Bitter Orange Slimming Capsules: Undeclared Drug Ingredient [press releast]> October 8, 2010. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm228870.htm
