Flibanserin Banned Again. Is It Denial or Safety?

femaile-viagraThe United States Food and Drug Administration (FDA) has thrice denied Sprout Pharmaceuticals’ application for flibanserin, the so-called “Female Viagra.” Since 2010, the FDA has insisted the non-hormonal, psychiatric medication does not meet its guidelines for effectiveness and long-term use, particularly given the reported side effects, namely nausea and vomiting, fatigue, dizziness, and sleepiness. That may sound like a typical list of side effects, particularly for an anti-depressant—the medication’s original purpose. Yet, the FDA stood behind its original decision and returned the application, citing side effects and insufficient evidence that the medication improved premenopausal women’s sex life.

Flibanserin attaches to the areas of the brain that affect sexual desire, specifically increasing dopamine and norepinephrine that control sexual excitement, and decreasing serotonin which controls sexual inhibition. Recent clinical trials tested flibanserin for its ability to increase the number of satisfying sexual experiences, the intensity of desire, and to reduce women’s painful emotions over their waning, or lost, libido. As reported by National Public Radio (NPR) on February 16, Sprout reports flibanserin increased women’s desire by 53 percent, doubled their number of satisfying sexual events, while decreasing their distress by 29 percent.

The FDA’s position has raised controversial accusations among feminists, who view the agency’s conservatism as sexist, referring to the over 20 FDA-approved treatments for male sexual disorders. Testing the highly commercialized Viagra on women added fuel to the fire. Results showed the medication performed well in women, if increased blood flow to the genitals were what were needed to treat midlife women’s worsening sexual experiences. Yet, as one study participant shared with NPR, women’s experiences often stem from a relational, emotional foundation rather than a physical one.

Others have documented this discrepancy, including Daniel Bergner of The New York Times in a 2010 article, “Unexcited? There May Be a Pill for That.” Until now, argues Sprout and their supporters, women have not had an effective means to address sexual dysfunction because so much attention has been paid to resolving men’s discomfort. Yet, as these women’s experiences attest, a solution for their midlife sexual health needs a multi-faceted approach that combines medication and/or supplements with individual or couples therapy. According to Bergner’s article, between 10 and 15% of women ages 20-60 years meet clinical guidelines for a condition known as Hypoactive Sexual Desire Disorder (HSDD). That percentage jumps to 30% if more anecdotal evidence is considered. For now, women seeking approved treatments can start with the North American Menopause Society’s “Effective Treatments for Sexual Problems,” a useful guide for issues ranging from low desire to painful sex.

Discouraged? Fret not. This ending may open a path to new solutions just by the conversations that might be started as a result of the FDA’s recent decision. Might it spark new initiatives to learn more about women’s complex sexual needs? Certainly, a frank broadcast like the one on NPR makes it easier for women to discuss our sex lives among ourselves, our doctors, and alas – our partners. So, talk amongst yourselves. Then, make some collective noise.

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About This Blogger

Kathy Stump

Kathy Stump writes from her home in Parkville, Missouri, a suburb of Kansas City. For the last two decades, she’s been raising two children, freelance writing, proofreading, and tutoring young readers. Local and regional magazines feature her articles on travel, historic sites, nutrition, and parenting. She’s also reviewed books for Kirkus Reviews and written academic essays for Anaxos, Inc. Reading, walking, and yoga are her favorite pastimes. In her previous life (before kids), Ms. Stump was a museum curator. She studied art history and historic preservation at Mary Washington University and holds a Master of Arts degree in Museum Studies and American Civilization from George Washington University.

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