WASHINGTON— The makers of a twice-rejected pill intended to boost libido in women will try once again this week to persuade regulators that the drug warrants approval as the first prescription treatment for low sexual desire in women.
But a new review released by the Food and Drug Administration shows government scientists still have concerns about whether the drug’s benefits outweigh its risks. The FDA review highlights several safety issues with flibanserin, including low blood pressure and fainting spells. Those problems increased when patients combined the drug with alcohol.
A panel of FDA experts will discuss those and other issues at a public meeting Thursday, before voting on whether to recommend the drug’s approval.
The ongoing saga of Sprout Pharmaceutical’s much-debated drug illustrates the complex politics and science surrounding women’s sexuality.