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Controversy surrounds FDA decision on women's libido drug

FDA could make history approving sex drug for... 02:31

UPDATE: TheFDA announced its approval of the drug flibanserin late Tuesday.

The U.S. Food and Drug Administration is expected to decide today whether to approve the first prescription drug treatment aimed at boosting women's libido.

The drug, called flibanserin, from Sprout Pharmaceuticals, was rejected by the FDA twice before, in 2010 and 2013.

But in June, an FDA advisory panel voted 18 to 6 to recommend approval on the condition that the drug's manufacturer develops a plan to limit safety risks. The FDA usually follows its panels' recommendations, though it is not required to.

A tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals. AP Photo/Allen G. Breed

Experts acknowledged that flibanserin's effect is not very strong, but noted that there is a need for FDA-approved treatments to treat women's sexual problems.

In clinical trials, women taking flibanserin reported between 0.5 and 1 additional sexually satisfying event per month than women taking placebo. They also reported higher levels of sexual desire, while scoring lower on measures of stress.

"These are very modest results," said Dr. Julia Heiman of the Kinsey Institute at Indiana University. "But on the other hand, even modest results can make a lot of difference when you're at a certain point in the clinical problem."

Some women's activists lobbied for the drug's approval to help close a gap in medical options for women.

"If it is approved, it will be a drug that's labeled for premenopausal women with HSDD, hypoactive sexual desire disorder, where low sexual desire causes distress," CBS News contributor Dr. Tara Narula said on "CBS This Morning."

Narula explained that the drug was originally developed as an antidepressant. It didn't work for that purpose, but some women did report an increase in sex drive. "This drug works centrally in the brain," she said. "It changes the norepinephrine, dopamine and serotonin levels. You take it every day and it takes a couple weeks to really reach peak effect."

The drug is frequently referred to as "female Viagra," but in fact flibanserin is a completely different medication and does not work the same way in the body as drugs that increase blood flow to the genitals to treat erectile dysfunction in men.

"A drug like Viagra is actually relatively simple when compared to a drug that could treat decreased libido, when so many factors -- medical, psychological, sleep, how your day was -- can be playing a role," said CBS News chief medical correspondent Dr. Jon LaPook.

There are also concerns about side effects from flibanserin, with 1 in 5 women experiencing an adverse effect while taking the drug, Dr. Adriane Fugh-Berman of Georgetown University told CBS News.

Side effects may include low blood pressure, sleepiness and dizziness, especially when flibanserin is combined with alcohol and some other drugs, Narula said.

If approved, Sprout Pharmaceuticals says the drug would be marketed under the brand name Addyi.

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