Washington: A pill being hailed as the “female Viagra” could soon be approved for sale in the US, despite safety risks. An advisory panel to medicines regulator the Food and Drug Administration (FDA) concluded that flibanserin should be made available with safety conditions from Thursday, the Independent said. The drug, made by Sprout Pharmaceuticals, would be the first on the market to treat low sexual desire in women. The FDA has twice rejected the drug but the panel voted by 18 to six to approve it with the introduction of a strict risk management programme.
Flibanserin’s benefits are medically marginal, the experts said, but can be meaningful for some patients. Some panelists reportedly expressed concerns that women taking it could pass out while driving a car or in other circumstances that could lead to serious injury or death.
Flibanserin was developed as an anti-depressant by Boehringer Ingelheim, which sold the drug to Sprout after the FDA’s advisory panel initially rejected it in 2010. The FDA turned down the drug again in 2013, saying the potential risks outweighed the benefits, which are termed by manufacturers as “satisfying sexual events”.
Thursday’s panel suggested measures including putting side-effect warnings on the box, letting only certified doctors prescribe it and establishing a patient registry and additional safety studies after flibanserin is on the market.
