A panel of independent experts recommended the Food and Drug Administration approve the first drug to enhance the female libido, with one big caveat.
In a closely watched meeting Thursday, a panel of agency advisers voted 18-6 to recommend approval of flibanserin, a drug used to boost female sex drives. The experts cautioned that there are safety concerns with the drug and that post-approval studies would be needed.
“It is not a magical, little pink pill,” said Marjorie Shaw Phillips, pharmacy coordinator for Georgia Regents Medical Center at the University of Georgia.
Any advertising for the new drug, if approved, should correctly describe how many patients it benefited and that it should not be taken with alcohol, said A. Michael Lincoff, director of the Cleveland Clinic’s Coordinating Center for Clinical Research.
If the FDA approves the drug, it would be the first on the market to treat low female sexual interest and arousal.
The manufacturer, Sprout Pharmaceuticals, previously tried to get it approved but was declined. It hopes additional clinical studies will be enough to satisfy agency concerns on safety.
The FDA does not have to abide by its advisers’ recommendations, but it usually does. An agency reviewer previously flagged safety concerns and modest effectiveness.
Several women’s groups said during the meeting Wednesday that the agency should disregard the recommendation and deny flibanserin.
“The data clearly show that taking flibanserin increases the likelihood of low blood pressure, fainting and other potentially serious adverse events,” according to written testimony from Cindy Pearson, executive director of the National Women’s Health Network.
Sprout said in a prior press release announcing the resubmission of its application that the drug’s safety profile was well characterized in clinical trials. The most common side effects were dizziness, nausea and sleepiness.
