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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In its second letter of the year, US Office of Prescription Drug Promotion says Xeris Pharmaceuticals’ television ad fails to include important risk information and misleadingly suggests Gvoke pre-filled syringe can be easily used.
US FDA’s approval of labeling supplements for the hypoactive sexual desire disorder drug followed Sprout’s appeal of a safety-related change order; boxed warning now states patients should wait at least two hours after drinking alcohol before taking flibanserin.
In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.