A drug to treat low female sexual desire should be approved with strict measures in place to ensure patients are fully aware of its risks, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.
Eighteen panelists voted in favor of approving the drug with a risk management program. Six voted against approval. None voted to approve the product without such a program.
The benefits of the drug are marginal, panelists said, but meaningful for some patients. Serious side effects include the risk of fainting at unpredictable times, accidental injury and low blood pressure.
The FDA, which has twice rejected the drug, flibanserin, is not obliged to follow the advice of its advisory panels but typically does so.
The panel's recommendation follows months of lobbying by the drug's developer, privately held Sprout Pharmaceuticals, aided by a number of women's advocacy groups which accused the FDA of gender bias, a charge the agency rejects.