Users of the first FDA-approved female libido medication can now drink alcohol while on it — just not two hours before taking the pill.
The Food and Drug Administration announced Thursday that Addyi users no longer have to avoid alcohol entirely. The change is a win for Sprout Pharmaceuticals, which has had trouble with sales of flibanserin, marketed as Addyi, because of the agency’s prior total prohibition on imbibing while using the medication.
Prior to Thursday’s decision, the drug had a boxed warning about alcohol, the strongest warning label the Food and Drug Administration puts on medications. There were concerns that the product could cause severe low blood pressure when combined with alcohol, but according to the FDA, users of the drug are safe drinking while using the once-a-day pill. The drug received initial approval by the the administration in 2015.
Addyi is intended to be taken at night, and despite the company pushing for full removal of the alcohol warnings, the FDA now says “women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime” or, if they have been drinking, to skip that night’s dose.
The new labeling may boost sales of the drug before another medication designed to boost female sex drive — bremelanotide — is set to gain FDA approval in June.
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