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.

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

GET STARTED

What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Daily Recap newsletter

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy