As FDA approves ‘pink Viagra’ for women, controversy persists – Los Angeles Times

After clearing the way for Viagra and more than two dozen other treatments to enhance the sex lives of men, the U.S. Food and Drug Administration on Tuesday gave its blessing to the first medication designed to increase sexual desire in women.

The FDA’s approval of flibanserin, often known by the nickname “pink Viagra,” reverses two earlier rejections of the pill as a treatment for hypoactive sexual desire disorder, or HSDD. The decision follows a public campaign challenging the agency to close a widening gap between the number of drugs available for men’s sexual health and those available to women.

The approval of flibanserin, which will be marketed as Addyi, offers women distressed by their low sex drive a once-a-day salmon-colored pill. Clinical trials presented to the FDA showed that compared with pre-menopausal women who got a placebo, those who took flibanserin reported a modest but measurable rise in sexual desire and increased their number of “sexually satisfying encounters” by roughly one per month, from a median of two to three to between 2 1/2 and four.

In tests, the most common side effects of the drug included dizziness, sleepiness, nausea and fatigue. Addyi should be taken at bedtime to reduce these risks, the FDA said.

Researchers estimate that about 8.3% of women between 30 and 70 in the United States suffer distress from lack of sexual desire. The condition, only recently deemed a medical disorder, appears to peak between the ages of 40 and 60.

Though many of those women may seek prescriptions for Addyi, the FDA said the drug could be marketed as safe and effective only for patients who had not yet reached menopause. For most women, that happens when they are in their late 40s or early 50s. However, once a drug wins FDA approval, doctors are free to prescribe it to patients as they see fit.

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