‘Female Viagra’ gets FDA approval

‘Female Viagra’ gets FDA approval

Women who have lost their sex drive will have a little pink pill to help them come October. On Tuesday, the U.S. Food and Drug Administration approved flibanserin, which will be sold as Addyi, for the treatment of sexual dysfunction in premenopausal women.

This is the first FDA approved treatment for sexual desire in men or women.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said in a statement announcing the approval. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

The approval is not without warnings. In fact, the agency approved the drug with a risk evaluation and mitigation strategy, or REMS, to ensure safety. Of greatest concern, an increased risk of severe low blood pressure, so low it can cause a temporary loss of consciousness. This is more of a concern in patients who drink alcohol while taking the drug.

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