FDA panel recommends against drug for increasing women's libido

Reported June 21, 2010

A Food and Drug Administration advisory panel Friday recommended unanimously against the agency's approval of the drug flibanserin, which is designed to boost women's libido. The panel said the drug's efficacy is not great enough to outweigh the side effects, which include fatigue, depression and fainting spells. The FDA is not required to follow its panels' recommendations, but it generally does so. Viagra

Filbanserin is the first drug that works on a woman's brain rather than attempting to physically stimulate her body. It stimulates one serotonin receptor in the brain and blocks a second one. Experimental results from a study of 5,000 women, reported last year, indicated that the drug produced an extra 1.7 satisfying sexual events each month over a baseline of 2.7 events, compared with an average increase of 0.7 such events produced by a placebo.

But in briefing papers prepared for the advisory committee meeting, FDA staffers concluded that the results were not sufficient to overcome the side effects of the drug. Many critics have also questioned whether lack of libido is an actual medical condition or simply a diagnosis created by pharmaceutical companies to sell new drugs. Some estimates suggest a $2 billion-per-year potential market for such drugs.