Thursday, June 9, 2011

Another Diet Drug Raises Concerns

Orexigen Therepeutics met with the FDA last week regarding Contrave, an investigational combination therapy of naltrexone and bupropion for the treatment of obesity and maintenance of weight loss. Although Orexigen has already evaluated Contrave in more than 4,500 patients, the FDA asked for a trial of between 60,000 and 100,000 patients showing that the drug doesn’t raise heart attack or stroke risk. Orexigen says it won’t pursue approval.

The risk vs. benefit ratio for most diet drugs leans toward risk, and the FDA’s reluctance to approve a new drug in this class may be due to experiences with previous diet drugs. Sibutramine (Meridia) was pulled from the market in October 2010 due to serious concerns about cardiovascular risks. Sibutramine continues to pose a threat to public health, however, by repeatedly surfacing in counterfeit and contraband formulations of over-the-counter weight loss and erectile dysfunction supplements.

To read more about sibutramine, see Psychiatric News at


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