FDA advisory committee supports weight-loss pill
December 8th, 2010
10:59 AM ET

FDA advisory committee supports weight-loss pill

An FDA advisory committee late Tuesday recommended approval of Contrave,  the first anti-obesity drug to get such an OK this year.  Two other weight-loss pills, Qnexa and lorcaserin, have been rejected.

Contrave would be used by overweight and obese patients whose initial body mass index is greater than 30 or 27 and greater with one or more health risk factors such as diabetes or hypertension.

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The commitee's vote was 13-7. The FDA has until January 31, 2011, to grant final approval.

In the clinical trials, subjects who took the drug lost at least 5 percent of their body weight.  But subjects had a small increase in blood pressure and pulse rate compared with the placebo group.  The advisory committee raised questions about the drug’s effect on cardiovascular health as the “hypertension-related adverse events was significantly higher” in the drug group compared with placebo subjects.

The committee voted 11 to 8 that the company, Orexigen should examine the drug's risk for major adverse cardiac events.  Read more from the FDA.

Earlier this year, the FDA advisory committee rejected Qnexa, citing concerns ranging from heart issues to psychiatric side effects.  Another drug, lorcaserin was rejected after questions about the drug’s effectiveness and tumor development in rat studies.

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