Study Questions Safety and Efficacy of “Female Viagra”

Flibanserin, the drug sometimes referred to as “female viagra,” offers minimum benefits and can significantly increase the risk of dizziness, somnolence, nausea, and fatigue, according to a recent study.

The drug was approved in August 2015 for the treatment of hypoactive sexual desire disorder in premenopausal women, despite concern over its safety and efficacy.
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In order to further evaluate fibanserin, researchers conducted an analysis of data from randomized clinical trials of the drug. Overall, the meta-analysis included 5 published and 3 unpublished studies involving 5914 women. Efficacy was measured using the number of satisfying sexual events (SSEs), eDiary sexual desire, and Female Sexual Function Index (FSFI) desire. Safety outcomes included the risk of adverse events including dizziness, somnolence, nausea, and fatigue.

Use of fibanserin resulted in an increase of 0.5 SSEs per month over placebo, a 1.63 increase in eDiary desire, and 0.27 increase for FSFI desire. Risk ratios for dissiness, somnolence, nausea, and fatigue in fibanserin vs placebo were 4, 3.97, 2.35, and 1.64, respectively.

“The data presented in this review suggest that the meaningful change caused by flibanserin is minimal,” researchers concluded.

“Overall, the quality of the evidence was graded as very low. Before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause.”

—Michael Potts

Reference:
Jaspers L, Feys F, Bramer WM, et al. Efficacy and safety of flibanserin for the treatment of hypoactive sexual desire disorder in women. JAMA Intern Med. February 29, 2015 [epub ahead or print].