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

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 warning letter to Sprout CEO Cindy Eckert, saying the ad...

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