STAT Plus: FDA warns Sprout for failing to mention risks in radio ad for Addyi
The Food and Drug Administration has admonished Sprout Pharmaceuticals for running a radio ad that omitted all possible risks associated with its controversial female libido pill and also for giving listeners a misleading impression about the extent to it can improve a woman’s desire.
In an Aug. 31 warning letter, the agency noted the ad for the pill, known as Addyi, failed to mention that women should avoid alcohol and certain antifungal medicines, which was described as “material information” that is found in a so-called black box warning on the product labeling. A boxed warning is considered the most serious form of risk information found in prescription drug labels.
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