An FDA panel just backed the ‘female Viagra.’ Critics say it’s a mistake. – Updated by Julia Belluz on June 4, 2015, 7:21 p.m. ET


1) A panel of advisers to the Food and Drug Administration just recommended the agency approve a new drug designed to boost womens’ sex drives.

2) Flibanserin — a pill dubbed the ‘female Viagra’ — has already been rejected by the FDA twice since 2010 out of concerns that its harms outweigh its benefits.

3) The 18-6 vote is considered a “major victory” for the drug, since the FDA more often than not adopts the advice of the expert group and same panel voted unanimously against flibanserin in the past.

4) Critics have raised questions about the efficacy of flibanserin. They’ve also accused the pharmaceutical industry of inventing the medical condition— hypoactive sexual desire disorder — that the drug would supposedly treat.

American women may be one step closer to the ‘female Viagra’

female viagra

(El Nariz /Shutterstock

Flibanserin (pronounced fluh-BAN-ser-in) is a daily pill made by Sprout Pharmaceuticals designed to treat low libido in premenopausal women. To date, the FDA has not approved it for sale — but the pressure to do so is growing.

On Thursday, a government advisory panel voted 18 to 6 to recommend that the FDA approve the drug — on the condition that Sprout can figure out how to minimize the safety risks to patients. That might entail requiring medical professionals to take a training course before being allowed to prescribe the drug, or making women who want the pink pills sign an agreement saying they won’t use birth control or alcohol while on flibanserin (since these two behaviors increased the risk of side effects).

About one in five women who took the drug have experienced side effects: most commonly, low blood pressure, dizziness, and fainting, increasing the risk of injuries such as concussions.

While Viagra improves men’s sexual performance, by increasing blood flow, the pink pill works on women’s brains, raising dopamine levels.

It’s not clear that the FDA will take the panel’s advice, particularly since the agency has questioned the drug’s effectiveness and safety in the past. As the New York Times reports, the results of clinical trials for flibanserin have been lackluster:

Three clinical trials testing flibanserin were consistent in their results. The women who took part were having an average of two to three of what they defined as “sexually satisfying events” per month when the studies began. Once they started taking the drug, the number of such events increased, but by no more than one event per month more than for women in the trial who got a placebo.

At the advisory committee meeting, the FDA gave a scientific presentation against the drug, arguing that it only resulted in eight more sexually satisfying events per year (when compared to placebo) and that side effects were common.

But the room was also filled with emotional testimony by women who feel they would greatly benefit from the medication. Sprout claims nearly one-tenth of premenopausal women suffer hypoactive sexual desire disorder.

Article continues:

http://www.vox.com/2015/6/4/8732723/female-viagra-fda

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