Latest News

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.

Continue to STAT Plus to read the full story…

Source link

Related posts

Pregnancy weight gain: what's right for you?


Algorithm Uses Individual Medical History to Predict Patient’s Chance of Survival in ICU


Antidepressant drugs may not work when neurons are out of shape


This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Accept Read More

Privacy & Cookies Policy