Skip to Main Content

Four years after approving the controversial Addyi pill for female sexual dysfunction, the Food and Drug Administration on Thursday softened a safety warning about mixing the drug with alcohol. But the agency also rebuked the manufacturer for insisting that the warning should be removed altogether, and took this unusual step after finding shortcomings in required post-marketing studies.

The FDA action is a mixed decision for Sprout Pharmaceuticals, which sought to revive Addyi sales by dispelling lingering long-running safety concerns over interactions with alcohol. The agency insisted that removing the warning entirely “was not acceptable for the protection of public health.” We asked Sprout for comment and will update you accordingly.


Here’s the backstory: At the time that Addyi was approved, the FDA required the product labeling to have a so-called black box warning that alcohol and Addyi should not be taken together, since the drug must be taken every day to be effective. The agency also ordered Sprout to conduct follow-up studies as a condition of the approval.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


Comments are closed.