Female libido drug: Is it safe and effective?

March 21, 2016

In August 2015, the U.S. Food and Drug Administration approved the medication flibanserin (Addyi) for use in premenopausal women with hypoactive sexual desire disorder.

Since then, some researchers have questioned its efficacy and safety, claiming the side effects may not be worth it.

Dr. Jordan Rullo of the Mayo Clinic Women’s Health Clinic is a member of the International Society for the Study of Women’s Sexual Health. She and her colleagues support the use of the drug for the subset of women who benefit from it.

"The recent meta-analysis on flibanserin puts into question its efficacy and safety, but this analysis has several flaws," Rullo says. "Because of these flaws, in my opinion, the findings of this meta-analysis do not change what we already know about the safety and efficacy of flibanserin."

For an explanation, visit the International Society for the Study of Women’s Sexual Health website at

During the clinical trials that tested the safety and efficacy of flibanserin, researchers looked at three things: self-reported increase in desire, more sexually satisfying events and levels of sexual distress. Results showed a modest benefit. Rullo says that for this group, the medication increased self-reported sexual desire, increased the number of satisfying sexual events and decreased self-reported stress.



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