Female Viagra May Get Approved by FDA This Week

Flibanserin, a drug designed to increase libido in women also known as female Viagra, could be approved by the U.S. Food and Drug Administration this week. FDA approval of the female Viagra would be unprecedented, as no such drug has ever been approved before.

WHAT IS FLIBANSERIN?

Unlike Viagra, flibanserin aims to raise libido by targeting the female brain’s pleasure center instead of the genitals. Proponents of the cite the lack of a female equivalent to Viagra. Unlike men, there is no drug on the market to combat persistent low sexual desire in women, a condition also known as hypoactive sexual disorder (HSDD).

But critics of flibanserin say that the negative side effects associated with the drug are too large for it to be released.

FLIBANSERIN’S CONTROVERSY

The female Viagra became controversial after trials found that the drug can cause fatigue, low blood pressure, nausea, fainting, and insomnia in patients taking it. And aside from these side effects, opponents of the drug say that the cause of HSDD can be psychological, not physical. For these reasons, flibanserin was rejected by the FDA drug safety advisory committee in 2010 and 2013.

Despite these concerns, it is likely that flibanserin will receive FDA approval this week. The drug was passed in June (with the condition that the manufacturer take measures to limit safety risks) by the drug safety advisory panel, which it usually follows in approval.

As Liz Szabo of USA Today reported, flibanserin manufacturer Sprout Pharmaceuticals has supported a large public relations campaign to get the the pill passed. It appears to be quite successful: 11 members of Congress and the National Organization for Women have written to the FDA in support of the drug.

EXPERTS AGAINST THE FEMALE VIAGRA

But their efforts haven’t stopped criticism of the drug, the effectiveness of which has also been questioned. Many in the medical community have voiced opposition. In July, open letters signed by about 200 health professionals to the FDA criticized the drug and advised against its use.

In an  piece for the Washington Post, Executive Director of the National Women’s Health Network Cindy Pearson said, “In clinical trials testing its effectiveness, flibanserin has either failed or barely passed. Only about 10-12% of women in trials benefitted from taking the drug.”


 

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