Sibutramine pulled from the market
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The weight loss drug sibutramine (Meridia) has been removed from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the FDA announced recently.
The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT), part of a post-market requirement to look at cardiovascular safety of sibutramine after European approval of the drug. The trial demonstrated a 16% 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 patients given sibutramine compared to those given placebo.
In light of the risk of heart attack or stroke, use of sibutramine was not justified by the very modest weight loss achieved by patients taking the drug, FDA officials said. Physicians are advised to stop prescribing the medication. Patients should stop taking it and talk to their health care provider about alternative weight loss and weight loss maintenance programs, the agency advised.