The first-ever female libido drug might not mix well with alcohol or other medications, a new report suggests.
Advisers to the Food and Drug Administration will meet Thursday to weigh safety concerns with flibanserin, a pill that, if approved, would be the first drug to treat low female sexual interest and arousal.
But the FDA released an advance report Tuesday highlighting concerns that the drug might not help women enough to make it worthwhile in light of the potential side effects.
So far, researchers have found flibanserin to have only modest effectiveness. In a 2013 study, women taking the drug experienced an average of 2.5 satisfying sexual events over a month-long period compared to 1.5 percent for women taking a placebo. In clinical trials, the effects of flibanserin plateaued at eight to 16 weeks of use.
On the flip side, one in five patients taking 100 milligrams of the drug have experienced side effects including sleepiness and sedation.
Women with reduced sexual desire would benefit from a libido-enhancing drug, the FDA wrote. But the agency stressed that benefits must outweigh side effects before it will approve flibanserin.
“This condition is clearly an area of unmet medical need,” the report says. “However, for any product intended to treat an unmet medical need, the FDA is still required to base its regulatory decisions on an assessment of whether the benefits outweigh its risks.”
