FDA Questions Risks of Drug to Boost Women’s Libido

Federal regulators evaluating a drug sometimes called “Viagra for women” are focusing on questions such as whether a small improvement in a woman’s sex life is enough to outweigh safety worries surrounding the medicine.

In reviewing the application by Sprout Pharmaceuticals Inc. for its drug flibanserin, the Food and Drug Administration is considering, among other things, whether an increase of 2.5 in the number of “sexually satisfying events” experienced a month is sufficient to truly help women who say they suffer from a low sex drive. That increase, found in one flibanserin study, compared with a rise of about 1.5 such events monthly among women getting only a placebo.

This is a novel issue for the FDA. It even held a workshop last fall devoted to the question of whether women’s sexual dysfunction is actually a medical condition. There was extensive testimony at the event from women who said their lack of libido was distressing to them.

On Thursday, an advisory panel will give its recommendations to the agency. Meanwhile, FDA staffers this week evaluated the evidence on the drug and concluded it does show a statistically significant improvement in women’s sexual desire. But agency reviewers asked “whether these observed effects outweigh the safety concerns.” Among those issues are low blood pressure, fainting and accidental injuries, along with sleepiness and nausea.

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The drug has been twice rejected by the FDA, in 2010 and 2013, and this week it reappeared with new data. Flibanserin isn’t really analogous to Viagra, which deals with men’s ability to have sex, whereas flibanserin deals with desire. But various women’s groups have argued that while drugs such as Viagra, Cialis and Levitra exist to help men, there is little available to help women with sexual dysfunction. They have also contended there is gender bias on the part of the FDA in the way it approves drugs for men.

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In clinical studies, fairly large numbers of patients dropped out because of side effects... “The problem with flibanserin is not gender bias, it is treatment failure,” said Thomas J. Moore, a drug-safety expert and director of the publication QuarterWatch, a publication on drug safety.

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http://www.wsj.com/articles/fda-questions-risks-of-drug-to-boost-womens-libido-1433280894