Sibutramine [Meridia]: Market Withdrawal Due to Risk of Serious Cardiovascular events

October 08, 2010 – Today, we learn that Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary market withdrawal of Sibutramine [Meridia], an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Sibutramine [Meridia] was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving Sibutramine [Meridia] lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of Sibutramine [Meridia]  after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given Sibutramine [Meridia] compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received Sibutramine [Meridia].

RECOMMENDATION

Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

More information can be found at FDA Drug Safety Communications for Sibutramine [Meridia] and at FDA Questions and Answers concerning Sibutramine [Meridia].