'Female Viagra' Approved by FDA Panel With Safety Restrictions

By Staff Writer | Jun 05, 2015 | 08:19 AM EDT

The tiny pink "female viagra" pill that was rejected twice is finally getting the backing from an FDA advisory panel.

If approved, Flibanserin would be the first female drug to battle female sexual dysfunction.

The pill is produced by Sprout Pharmaceuticals and heavily lobbied by feminist and consumer advocacy groups. The advisory committee to the Food and Drug Administration voted in favor of Flibanserin by 18-6.

However, certain safety restrictions must be met by the manufacturer to decrease the health risks of women who might be taking the drug, the New York Times reports. Doctors might also need to be certified to prescribe the drug because of its potential side effects.

During the recent panel review, many experts were concerned about the potential side effects of the pink pill. According to FSD, its risks and potential side effects include: fatigue, dizziness, nausea, and low blood pressure, upset stomach, depression, constipation and abdominal pain.

"I am elated, very happy to hear this," Dr. Margery Gass, director of the North American Menopause Society and sexual dysfunction expert, told CNN about Thursday's results. "I think women are going to be very appreciative of having something they can try for this problem."

The controversial campaign for the drug, which included a signature campaign, was placed under the group called Even the Score, who accused the FDA with gender bias. The group claims that the agency approved many medicines that treat male sexual problems but none for females with low libido.

The FDA hit back with a response that rather than sexism, the agency found that the drug had "modest" benefits and its cons outweigh its pros, according to The Wall Street Journal.

Other women's groups have slammed Even the Score for trying to use women's rights to get a drug with potentially dangerous health risks approved.

"As a feminist, I'm delighted people are taking women's sexual issues seriously, but recommending approval for this drug isn't the correct response," Cindy Pearson, the National Women's Health Network executive director, said. "This sets a low bar."

Dr. Adriane Fugh-Berman, from Georgeman University, also expressed her disapproval and called out the pink Flibanserin pill as "a mediocre aphrodisiac with scary side effects."

"To approve this drug will set the worst kind of precedent - that companies that spend enough money can force the F.D.A. to approve useless or dangerous drugs," said Dr. Fugh-Berman, who is also PharmedOut's director.

Related Stories

Latest News