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STAT Plus: FDA chastises maker of the Addyi female libido pill over trying to remove alcohol safety warning



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.

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