Flibanserin, widely hailed as the “female Viagra,” was approved with much fanfare last August. A new meta-analysis and accompanying editorial question the efficacy and safety of the drug, and even suggests non-clinical factors played a role in the drug’s approval. Flibanserin was approved for hypoactive sexual desire disorder (HSDD) in premenopausal women. A new meta-analysis reviews the data from a number of studies on efficacy and safety. Data from five published and three unpublished studies of nearly 6000 women showed flibanserin increased satisfying sexual events by 0.49 per month compared to placebo (95% confidence interval [CI], 0.32-0.67). Other measures included eDiary sexual desire and Female Sexual Function Index, both of which showed only modest change compared to placebo. The risk ratio for discontinuation due to adverse events was 2.19 (95% CI, 1.50-3.20). Most common adverse events were dizziness, somnolence, nausea, and fatigue. Women’s mean global impression of improvement scores indicated minimal to no change. The authors concluded that flibanserin, on average, resulted in a one-half additional satisfying sexual event per month while significantly raising the risk of dizziness, somnolence, nausea, and fatigue. The risks of side effects are significantly amplified with concurrent alcohol use (JAMA Intern Med Published online Feb. 29, 2016. doi:10.1001/jamainternmed.2015.8565). In a scathing accompanying editorial, Drs. Steven Woloshin and Lisa M. Schwartz probed the approval process for this drug, including the drug company’s support of an adequacy group to lobby the FDA for approval after multiple agency rejections. “The FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial and unnecessary uncertainty about its dangers. Women with distressing sexual desire problems need good treatments. We all need a new drug approval process that delivers good decisions based on adequate evidence”(JAMA Intern Med Published online Feb. 29, 2016. doi:10.1001/jamainternmed.2016.0073).
Flibanserin, on average, resulted in a one-half additional satisfying sexual event per month while significantly raising the risk of dizziness, somnolence, nausea, and fatigue.
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