FDA Notice Regarding Manufacturer Withdraw of Meridia

October 14, 2010 9:04 AM

Due to the increased risk of heart attack and stroke associated with the weight loss medication Meridia^® (sibutramine), Abbott Laboratories will voluntarily withdraw the drug from the US market. As reported in a FDA news release, the agency approved Meridia in 1997 for weight loss in obese patients and certain overweight patients with additional risks for heart disease. In reviewing data from a required post-market assessment of Meridia’s cardiovascular safety, FDA determined that there is a 16% increase in the risk of serious heart events, including non-fatal heart attack and non-fatal stroke. While earlier data had shown that patients using Meridia lost 5% more of their body weight compared with those who took a placebo while dieting and exercising, the post-market study showed that Meridia made only a small difference in weight loss.

Overall, it was determined that the risk of cardiovascular events outweighed the small weight-loss benefits of the drug. FDA advises that health care providers stop prescribing Meridia and that patients stop taking it. Patients should seek advice from their health care provider as to alternate weight loss treatments and programs.