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Addyi Radio Ad’s Lack Of Alcohol Risk Information Elicits New Clash With US FDA

 
• By Brenda Sandburg

Agency directs Sprout to disseminate corrective messages about the risks associated with the female sexual dysfunction pill. Sprout previously challenged FDA’s alcohol labeling requirements.

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FDA objects to radio ad for Sprout's hypoactive sexual desire disorder drug Addyi • Source: Shutterstock

The US Food and Drug Administration reprimanded Sprout Pharmaceuticals, Inc. for a radio advertisement for Addyi (flibanserin) that fails to disclose the risk of taking the hypoactive sexual desire disorder drug with alcohol and requested that it issue a corrective piece.

The agency’s Office of Prescription Drug Promotion sent a

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