Increases Sexual Satisfaction

Despite promising headlines, the benefits of flibanserin for women’s libido are “marginal” considering its side-effects, and its approval by U.S. regulators was based on weak science, doctors say.

According to media reports Monday, Flibanserin (Addyi) was twice rejected by the U.S. Food and Drug Administration as a treatment for low or “hypoactive sexual desire disorder” in premenopausal women before it was given the green light in August 2015.

Now researchers in the Netherlands have combed through five published and three unpublished studies on 5,900 women. The systematic review and meta-analysis of the drug’s safety and efficacy is published in Monday’s issue of JAMA Internal Medicine.

The benefits of flibanserin for women’s libido are “marginal” considering its side-effects, and its approval by U.S. regulators was based on weak science, doctors say.

Flibanserin (Addyi) was twice rejected by the U.S. Food and Drug Administration as a treatment for low or “hypoactive sexual desire disorder” in premenopausal women before it was given the green light in August 2015.

Now researchers in the Netherlands have combed through five published and three unpublished studies on 5,900 women. The systematic review and meta-analysis of the drug’s safety and efficacy is published in Monday’s issue of JAMA Internal Medicine.

The most common side-effects of the drug included four times higher risk of dizziness and sleepiness, double the risk of nausea and slightly less than double the risk of fatigue, the reviewers found.

Jaspers said given the current findings, she wouldn’t recommend that the drug be approved in the European Union. Rather, she’d like to see more studies on women with chronic diseases and taking different types of medications before it’s implemented in clinical guidelines.

“The flibanserin saga is unsatisfying,” Dr. Steven Woloshin and Dr. Lisa Schwartz of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., said in  journal commentary published with the review.

“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 said all FDA clinical reviewers, who knew the data the best, voted to reject the drug, but they were overruled by senior administrators who acknowledged the drug’s limited efficacy but stressed unmet medical needs for women.

Importantly, combining flibanserin with alcohol and other common drugs can cause dangerous hypotension and syncope or fainting. The FDA required its most serious warnings, known as black box warnings, for these potential adverse events.