FDA approves female sex pill, but with safety restrictions

WASHINGTON (AP) — Federal health officials on Tuesday approved the first prescription drug to boost sexual desire in women, a milestone long sought by the pharmaceutical industry.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Dr. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”

But safety restrictions on the daily pill, called Addyi, mean it will probably never achieve the blockbuster sales of men's impotence drugs like Viagra, which have generated billions of dollars.

The new drug's label will carry a bold warning that combining it with alcohol can cause dangerously low blood pressure and fainting.

Those problems can also occur if the drug is taken alongside certain common medications, including drugs used to treat yeast infections.

The Food and Drug Administration approval on Tuesday marks an unusual turnaround for the agency. The FDA previously rejected the drug twice due to lackluster benefits and worrisome side effects.

Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.