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FDA Approves 'Female Viagra'


A tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters.
A tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters.

The U.S. Food and Drug Administration has approved a libido-enhancing drug for women that has been dubbed "Female Viagra."

The approval of the drug (flibanserin), which the FDA twice rejected before and now will be marketed as Addyi, comes with a series of explanations reflecting the agency’s concerns about serious side effects. These include a boxed warning that highlights the risks of low blood pressure and fainting in patients who drink alcohol while taking the drug, and a requirement that doctors complete a training course before being allowed to prescribe the drug.

Opponents of the drug say it's not worth the side effects, which also include nausea, drowsiness and dizziness. They point out that the FDA rejected the drug twice, in 2010 and 2013, because of those risks.

The drug is actually the first approved to treat a flagging or absent libido for either sex. Viagra and other drugs available for men are approved to help achieve erections, or to treat certain deficiencies of the hormone testosterone, not to increase desire.

The drug will be available to women starting in October.

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