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FRIDAY, Oct. 8 (HealthDay News) -- Abbott Laboratories, maker of Meridia (sibutramine), agreed to voluntarily withdraw the obesity drug from the market because it might place users at increased risk of heart attack and stroke, according to an Oct. 8 announcement from the U.S. Food and Drug Administration.
The agency requested the action following review of data from a trial of about 10,000 patients -- randomized to Meridia or placebo over 60 months -- initiated to examine the cardiovascular safety of the drug, which was approved for weight loss by the FDA in November 1997.
The Sibutramine Cardiovascular Outcomes Trial showed a 16 percent increase in risk of major adverse cardiovascular events in patients taking the drug compared to placebo recipients. Weight loss in the treatment group was relatively modest, and the FDA concluded that the risks associated with the drug outweighed its potential to help patients lose weight.
"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," John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."
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