‘Female Viagra’ Pill: FDA Advisory Panel Recommends Approval Of Flibanserin

An FDA advisory panel has voted to recommend that the “female viagra” pill be approved. This is not the first time this pill has been voted on by the FDA. Safety concerns have caused the FDA to vote against the female pill, manufactured by Sprout, twice before.

Viagra has helped men with erectile dysfunction for over 17 years. After the second time the FDA voted against a female version of the pill, women’s groups began to question why a pill has not been approved for them that deal with sexual dysfunction.

Two groups, Even The Score and Women Deserve, started petitions and created a lobbying effort on behalf of women who have sexual problems. These groups were saying that 26 medications exist for men while none exist for women when it comes to treatment of sexual dysfunction. Even The Score was able to obtain over 40,000 signatures in support.

The “female viagra” pill, flibanserin, has been questioned in the past on its validity. Evidence given to the FDA showed that flibanserin produced additional 0.7 “sexually satisfying events” per month. During the clinical trial phase, 14 percent of the women involved in the study, dropped out due to adverse effects from the medicine. The clinical trial showed that a female taking flibanserin had 10 times the risk of dizziness and four times the risk of sleepiness. Thea Cacchioni, an assistant professor of women’s studies at the University of Victoria in British Columbia, comments on these adverse effects.

“These may sound minor, but since this drug was tested on a highly select group of women, there is concern over what would happen if a wide population of women take this drug on a daily basis? What drug interactions will we see? Is there a risk of impaired driving?”

Cacchioni was confident that the FDA would not approve the “female viagra” pill.

“I have faith that the FDA will stand its ground and not approve flibanserin. If they do, they are sending a very dangerous message – that drug companies and their marketing machines can pressure them into approving drugs that are unsafe and ineffective.”

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Josh Bloom, director of chemical and pharmaceutical sciences at The American Council on Science and Health in New York City, shares the same belief of Cacchioni.

“Do the benefits outweigh the risks? The FDA has already said no three times. This should have been over with long ago.”

Now that the “female viagra” pill has been recommended for approval, the question becomes why did they change their mind?

[Image via Nbcnews.com]