WASHINGTON – The makers of a pill intended to boost sexual desire in women will try again this week to persuade regulators that the drug warrants approval after two rejections.
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 and some other medications, according to the document.
A panel of FDA experts will discuss the drug at a public meeting Thursday, before voting on whether to recommend its approval.
The ongoing saga of Sprout Pharmaceutical's much-debated drug illustrates the complex politics and science surrounding women's sexuality.
For decades, drugmakers have tried unsuccessfully to develop a female equivalent to Viagra, the blockbuster drug that treats men's erectile dysfunction by increasing blood flow. But disorders of women's sexual desire have proven resistant to drugs that act on blood flow, hormones and other simple biological functions.
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