• New York Times, Thursday, June 17, 2010 10:29 AM

A Food and Drug Administration staff report has recommended against approving a drug that German drug manufacturer Boehringer Ingelheim claims will restore women's libido, Duff Wilson reports. The FDA says that the drug maker failed to make its case and that possible side effects such as dizziness, nausea and fatigue outweigh the drug's potential benefits.

An FDA advisory panel of experts will vote tomorrow on whether to recommend that the agency approve the pill. The drug has stirred a debate over what constitutes a normal range of sexual desire among women.

"This is a real disease," says Dr. Peter J. Piliero, Boehringer's director of medical affairs in the U.S. "There's an unmet medical need among premenopausal women to have a treatment." Many experts say that sexually dysfunction in women is much harder to diagnose than in men. Critics contend the company is overstating the prevalence of the condition, which could cause anxiety in some women.

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