Rotterdam, The Netherlands—A drug approved to treat low sexual desire in premenopausal women appears to have marginal clinical benefits as well as some troubling adverse effects, according to a recent Dutch study.

The drug, flibanserin, was approved last year by the FDA. Results of a review of eight clinical trials—five published and three unpublished—involving 5,914 women were published recently in JAMA Internal Medicine.

The study team led by Erasmus University Medical Center researchers found that treatment with flibanserin was, on average, associated with one-half additional satisfying sexual event per month. At the same time, the drug increased risk of dizziness, sleepiness, nausea, and fatigue, the report notes.

Pooled mean differences for change in satisfying sexual events from baseline were 0.49, with the risk ratio for study discontinuation due to adverse events at 2.19. The risk ratio for dizziness, 4.00, was especially high, followed by 3.97 for somnolence, 2.35 for nausea, and 1.64 for fatigue, according to the results.

Quality of evidence in the randomized clinical trials reviewed was rated as very low by the authors because of limitations in design, the indirectness of evidence, and more favorable efficacy outcomes in published compared with unpublished studies. They call for further research to include women from diverse populations, particularly those with coexisting illnesses, medication use, and surgical menopause.

Although researchers began the study to evaluate the efficacy and safety of the medication for treatment of hypoactive sexual desire disorder (HSDD), that condition was replaced by female sexual interest/arousal disorder with the introduction of the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition).

Still, study authors point out, “The findings of this review suggest that the benefits of flibanserin treatment are marginal, particularly when taking into account the concurrent occurrence of AEs [adverse events].”

“The flibanserin saga is unsatisfying,” add Steven Woloshin, MD, MS, and Lisa M. Schwartz, MD, MS, of the Dartmouth Institute for Health Policy and Clinical Practice in a related commentary.

“The FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial – and unnecessary – uncertainty about its dangers,” Woloshin and Schwartz emphasize. “Women with distressing sexual desire problems need good treatments. We all need a drug approval process that delivers good decisions based on adequate evidence.”

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