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Spokane, Washington  Est. May 19, 1883

FDA panel gives OK to women’s libido pill

Los Angeles Times

WASHINGTON – American women may soon have access to a controversial libido-enhancing pill dubbed “pink Viagra” after a government panel on Thursday gave its backing to what would be the first FDA-approved drug for the treatment of female sexual dysfunction.

In an 18-6 vote, a panel of Food and Drug Administration experts recommended allowing the experimental drug, flibanserin, to be sold in the U.S. as long as certain safety precautions are taken to minimize potential side effects, which include low blood pressure, dizziness and fainting.

Some say drugs such as flibanserin could enhance women’s sex lives in the same way erectile-dysfunction medications have improved men’s. But experts in female sexuality scoff at the notion that a 100-milligram pill, taken daily at bedtime, will turn women’s sexual desires on with the ease of flipping a light switch. In clinical trials, the drug had a small but measurable effect.

The vote is a major victory for the drug’s owner, North Carolina-based Sprout Pharmaceuticals. Two previous attempts to win approval of flibanserin before the same FDA committee failed amid questions about the drug’s risks and efficacy. Though a final decision will be made in the coming months by FDA Commissioner Stephen Ostroff, the panel’s recommendation is likely to weigh heavily.

“I think it’s a major step forward in better understanding of women’s sexuality and better understanding of women being able to take control of their own sexuality in a healthy way,” said National Organization for Women President Terry O’Neill.

The debate over developing and marketing a pill to treat women’s sexual problems has run for years as scientists and pharmaceutical companies rushed to duplicate the success of the blockbuster drug Viagra.

Supporters of flibanserin complained that the FDA has approved several sexual-dysfunction drugs for men, including Viagra, but not a single one for the millions of American women suffering from low libido. Critics accused the agency of a sexist double standard.

Opponents argue that pharmaceutical companies are seeking to profit by medicalizing what they say is often an emotional or relationship issue.

If ultimately approved, flibanserin would be the first nonhormonal treatment for “hypoactive sexual desire disorder,” or HSDD, in premenopausal women. The condition afflicts some 4.8 million premenopausal women, but physicians have had essentially nothing to offer them, according to Sprout.

Critics are still urging the FDA to reject the drug, citing its side effects and lackluster results.

Chief among the safety concerns is evidence from clinical trials showing that some women taking flibanserin are at higher risk of low blood pressure and fainting. Panel members were particularly concerned about the risk when flibanserin is taken with alcohol.