FDA loosens booze ban for Sprout libido drug

April 12, 2019

The US FDA announced that women taking Sprout Pharma's female libido pill, Addyi, do not need to completely avoid alcohol.

The FDA ordered Sprout to make changes to the drug's label to reflect that patients should stop drinking two hours before taking Addyi at bedtime or to skip the dose that evening. The changes were based on post-marketing studies by Sprout.

The FDA approved the drugmaker's highly-discussed Addyi in August 2015, but the approval came with a strict monitoring program to guard against safety risks associated with the drug. Sprout had resubmitted the New Drug Application for flibanserin three times amid much controversy before being granted approval.