Recommendation for Female Libido Drug Gets Mixed Reviews

An FDA panel’s recommendation earlier this month for what’s known as the “female Viagra” is being hailed in some quarters, and criticized in others.

The first group believes the drug addresses a long-overdue acknowledgment that women’s sexual health has been treated as secondary to men’s. The second group believes the drug’s benefits do not outweigh its potential harms.

Some people also believe that its approval invites “disease-mongering” among women in the same way that promoting testosterone for normal aging does among men. (See the recent story in the Washington Post, “Sell a disease to sell a drug,” about the bogus idea of “low-T.”) They believe women are too often encouraged to seek a medical treatment when the problem might be rooted in relationship difficulties or other life stressors.

The drug, flibanserin, is supposed to spark the sexual desire of premenopausal women who are healthy except for lagging libido, a condition known as hypoactive sexual desire disorder (HSDD).

As described by the Washington Post, Sprout Pharmaceuticals, developers of the drug, presented to the FDA panel the results of clinical trials that showed the drug worked better than a placebo (a fake, or inert pill) to boost women’s sexual desire, increase the number of sexually satisfying events and lower distress about their condition.

The company claimed that as many as 6 in 10 women in the trials had benefited from taking flibanserin. “But some committee members,” according to The Post, said that “after adjusting the data to take the placebo effect into account, the drug wound up helping only about [1 in 10] of the women in the trials.”

Members of the public also spoke at the hearing for and against recommending approval. (See our blog last week, “An Astroturf Grassroots Campaign.”)

The FDA approved Viagra for men in 1998, as well as several similar drugs since then, but the FDA has not approved any medications for women’s sexual function, which the agency described as an “unmet medical need.”

Flibanserin was developed as an anti-depressant, and works on neurotransmitters in the brain that affect sexual desire. Viagra works by improving blood flow. Viagra is taken only when a man wants to have sex. Flibanserin is intended as a daily pill.

In the hearing, FDA medical officers expressed concern over potential side effects, and wondered if the drug’s benefits were significant enough to override them.

The most common problems are a drop in blood pressure, dizziness, nausea, fainting and sleepiness. “Some women had to stop taking the drug because of the side effects,” The Post reported, “and one reacted so poorly that she had to be hospitalized.”

Drug makers have tried twice before to get flibanserin approved, and the FDA has declined because it said the potential side effects outweighed its benefits. And still this month the panel assessed the drug benefit as “moderate” or “marginal.”

There’s also concern about flibanserin’s interaction with other drugs, particularly hormonal birth control pills and alcohol, and the potential to increase car accidents, falls and other mishaps.

And because most flibanserin trials lasted only one year to 18 months, some panel members said that wasn’t enough to assess other risks that might not present for a while.

Some people who spoke against approval during the hearing acknowledged that although low sexual desire was a real and painful condition, flibanserin wasn’t the right treatment. They claimed its success was more about slick marketing by Sprout than about good science.

Some accused the pharmaceutical company of deceiving women “into taking a drug that doesn’t work better than drinking a glass of wine or two, and could end up killing us,” The Post quoted Liz Canner as saying. She produced the documentary film “Orgasm, Inc.,” about the medical community’s quest for “female Viagra,” and the huge amounts of money to be made from this market.

Although the advisory committee approved the drug, it recommended that certain conditions apply before final approval. They include warning labels against use by pregnant women and against alcohol and the use of certain drugs while taking flibanserin.

The FDA usually follows the recommendations of its advisory panels; its decision about flibanserin is expected by the end of the summer. You can read the committee’s report here.

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