April 11 (Reuters) - The U.S. Food and Drug Administration said on Thursday women taking Sprout Pharmaceuticals Inc’s female libido pill, Addyi, need not 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.
Approved by the FDA in August 2015, Addyi is meant to be taken daily.
The drug carries a boxed warning, FDA’s strictest, about potentially dangerous low blood pressure and fainting, especially when taken with alcohol. Patients taking the drug were previously told to completely avoid alcohol.
The changes recommended by the FDA were based on post-marketing studies by the company, which are required in some cases after approval of the drug.
Sprout was bought by Valeant Pharmaceuticals International, now known as Bausch Health Cos Inc in 2015, and then sold back to its former owners after two years. (Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta)