The FDA is cautioning physicians to stop prescribing sibutramine after trial results find that the benefits don't outweigh the risks.
The FDA is asking Abbott Laboratories to voluntarily withdraw sibutramine, a weight-loss medication marketed as Meridia, from the market after finding that it is linked to an increased risk for cardiovascular events. Physicians are being urged to stop prescribing the drug and contact patients who are taking it.
In a news conference held last week, John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said that there were known risks associated with sibutramine when the agency approved the drug in 1997 for weight loss and maintenance of weight loss in obese patients, according to an FDA statement. At the time, he said, the FDA thought the potential cardiovascular benefits obese patients could achieve through weight loss outweighed those risks.
However, after completing its review of findings from the Sibutramine Cardiovascular Outcomes, or SCOUT, trial, which concluded last year, the FDA changed its tune. Patients who took sibutramine during the five-year SCOUT trial lost an average of only 2.5% more weight than did patients taking placebo, according to Jenkins
"The data for this trial showed that patients treated with sibutramine did not experience the expected cardiovascular benefit from losing weight," he said. “Instead they experienced a 16 percent higher rate of cardiovascular events, such as heart attack and stroke, compared to patients who took placebo."
In addition to its recommendation to stop prescribing the drug, the FDA issued the following recommendations for physicians:
Jenkins said sibutramine can increase heart rate and blood pressure while a patient is taking the drug, but FDA officials are unaware of any long-term problems among patients after they stop taking the medication.
Members of the FDA advisory panel that met to review data from the SCOUT trial also voted not to recommend approval of lorcaserin, a new weight-loss drug manufactured by Arena Pharmaceuticals, due to safety concerns. Panel members also voted in July against recommending approval of Qnexa, a weight-loss drug produced by Vivus Inc. that combines phentermine and topiramate.
A third weight-loss drug, Orexigen Therapeutics Inc.'s Contrave, is expected to be reviewed by the FDA panel this year. That product contains naltrexone and bupropion.
Despite the withdrawal of sibutramine and the rejection of two other weight-loss products by its advisory committee, Jenkins said the FDA supports the development of safe and effective weight-loss products because of the serious health problems associated with obesity.
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Were you surprised to learn that another weight loss drug is being pulled from the market? Does this impact the course of treatment that you might recommend for overweight patients?