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Could ‘female Viagra’ get FDA’s vote this week?

UPDATE: The controversial drug has been approved by the FDA. It did come with a strong warning about potentially low blood pressure and fainting when the drug is combined with alcohol.

Women, listen up! Having trouble getting “in the mood?” It looks like a female version of Viagra could be headed your way…or not?

The Food and Drug Administration will decide Tuesday whether a “little pink pill” promoted as a catalyst for female sexual desire should be on the market as a treatment for low libido in women. The Sprout Pharmaceuticals-produced pill is called flibanserin, but is popularly (though incorrectly) known as “female Viagra.”

Unlike Viagra, flibanserin tinkers with the chemistry of a woman’s brain and it was originally introduced as an anti-depressant, according to Telegraph. Then, subjects in chemical trials claimed that they had “slight increases in sexually satisfying events.” As a result, the “sexual” affects became the focus.

Sprout’s CEO Cindy Whitehead said that for women, it is “not about blood flow.” “Desire is happening in the brain,” Whitehead said.

The pill is not Viagra and the manufacturer agrees. The pill is taken on a day-to-day basis and should only be taken by pre-menopausal women whose dopamine and norepinephrine levels are in need of a little re-calibration.

But is it even successful? Women in clinical trials only reported 0.5-1 extra sexually satisfying events in one month in comparison to those taking the placebo, Telegraph reports. And it comes with side effects such as dizziness, fatigue, nausea, insomnia, fainting and falling blood pressure when combined with alcohol.

It doesn’t seem like the answer to your problems, ladies. It actually sounds a bit risky.

Flibanserin has had some problems on its journey to getting approved. One reason is that little is known about the science of desire and another is that there is still great debate on what “normal” sexual desire means, Washington Post reports.

This will be the FDA’s third time to consider the drug since 2010, according to USA Today. So what’s different this time?

The drug has a major push from an advocacy group, Even the Score, and high-profile supporters such as 11 members of Congress and the National Organization for Women. In other words, the right people are in their corner this time.

In June, an FDA advisory panel voted to recommend flibanserin’s approval if Sprout took steps to lessen the pill’s risks. But did they listen?

Critics claim argue that the drug has not changed and that Sprout is hiding behind their publicity campaign instead. Approximately 200 health professionals signed letters in July stating that the drug is barely better than a placebo when it comes to raising libido levels and that the side effects could effect women’s health in a negative way.

Lead author of one letter and associate professor at the University Medical Center in Washington Adriane Fugh Berman wrote: “Approving flibanserin will not only unleash an unsafe drug onto the U.S. market, but will send a message to industry that pressuring the FDA through public relations campaigns can get a drug approved.”

Will the FDA approve the drug, or will it fail again?

About Meredith Rodefer

Meredith Rodefer

Meredith Rodefer is a freelance writer, who focuses on anything from lifestyle blogging to hard news, and dancer. Beyond Youth Independent, she has written for sites such as Natmonitor.com, CheekyChicago.com and FamilyFocusBlog.com.
Contact Meredith: meredith.rodefer@youthindependent.com

  • Beth C

    The FDA declined to approve Testosterone products saying they didn’t know long term effects of Testosterone in women. (Wow, suddenly everyone’s doctor would become an idiot and not be able to do patient monitoring?)

    They approved Thalidomide. They approved Botulism. They approved Accutane. Yeah, I know, I know, but these are dangerous black-box warning drugs. And now they decline to approve this because the results are weak and it lowers blood pressure (so take it before bed?)

    The FDA would decline to approve Oxygen if it weren’t already ‘grandfathered’ in. The whole idea that my doctor is too dumb to prescribe me something or read peer reviewed research unless a panel of 10 men say it’s okay first is just insulting. That ad campaign, even the score, is dead on, EVEN IF the drug is marginally effective.