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Female Libido Drug’s Safety Questioned by U.S. Regulatory Staff

The safety of an experimental pill to treat low sexual desire in women, potentially the first of its kind in the U.S., is under scrutiny as regulators raised concerns the drug can act as a sedative and cause fainting.

The question of whether the modest benefit of the drug, flibanserin, is enough to outweigh serious side effects will be the topic of a meeting of advisers to the Food and Drug Administration on Thursday. The agency rejected the pill a year and a half ago, asking closely held Sprout Pharmaceuticals Inc. to perform more trials.