The little pink pill, often dubbed “Viagra for women,” in clinical studies had a modest effect in boosting women’s interest in sex. But there are “serious risks” of low-blood pressure and fainting with the drug, especially when taken while drinking alcohol, an FDA analysis said. Because of the side effects, the FDA is requiring that doctors and pharmacists be specially certified to deal with the drug.

The side effects could give doctors pause if their patients demand the drug.

The approval of the drug for premenopausal women, to be called Addyi, follows a lobbying campaign by the drug’s maker, Sprout Pharmaceuticals Inc., and by a group called Even the Score, partially sponsored by Sprout. In an online petition, Even the Score, says the FDA “has approved 24 drugs for the treatment of male sexual dysfunction. For women, that number is zero.”

The best-known of the drugs for men, such as Viagra and Cialis, affect blood flow and men’s physical ability to have sex. Addyi, generically called flibanserin, is designed to increase sexual desire in women who are distressed by low libido.


There is considerable debate as to whether low libido in women, termed “hypoactive sexual desire disorder,” even exists as a physical condition—and if it does, whether a pill can fix it.

“I would say no and no,” said Leonore Tiefer, a clinical associate professor in the psychiatry department at New York University School of Medicine. In Dr. Tiefer’s view, the problem stems more from “hopelessness, self-critical feelings and lack of confidence.” She said that “without question,” psychiatric therapy can improve these feelings in women—and their sex drives—as much or more than Addyi.

Last fall, the FDA held a workshop focused on women’s sexual dysfunction and exactly what it is. Many women testified they had lost interest in sex and experienced difficulties in relationships as a result.

Cindy Whitehead, chief executive officer of Sprout Pharmaceuticals, noted that an FDA advisory committee voted 18-6 to approve the drug, which is taken once daily. She said the improvement in women’s symptoms with Addyi “may seem modest but it is quite significant” to the women involved. The label for the drug, which is to be launched Oct. 17 according to Sprout, states that if a woman doesn’t respond to the drug within eight weeks, she likely won’t respond at all.

A 2013 medical-journal study of 542 women on the drug and 545 women on a placebo found the main side effects were drowsiness, dizziness and nausea. Those symptoms caused 9.6% of women to discontinue the drug, compared with 3.7% of women taking a placebo.

An FDA analysis also found that women taking Addyi and hormonal contraceptives “tended to have a higher incidence of adverse events” compared with those on a contraceptive and placebo. The FDA’s analysis of the drug’s safety found “serious risks of hypotension and syncope,” meaning low blood pressure and fainting.

To measure the drug’s effectiveness, the FDA looked at users’ self-reports of “satisfying sexual events,” which initially were at a median average of about two to three a month per person. Addyi users had a median increase, compared with placebo users, of 0.5 to one such event a month, an FDA analysis found.

As to whether this conveys a perceivable benefit to those taking the drug, Cindy Pearson, executive director of the National Women’s Health Network, said women in the study had “about one more time a month where they’re happy. That’s pretty crummy.”


Updated Aug. 18, 2015 8:13 p.m. ET

Write to Thomas M. Burton at [email protected]

Source: Wall Street Journal Health