Drinking alcohol with Addyi (flibanserin), also called Female Viagra, appears somewhat less dangerous than initially thought. The U.S. Food and Drug Administration (FDA) has ordered a warning label change to reflect the new data over the objection of its manufacturer – Sprout Pharmaceuticals.
The FDA said Sprout Pharmaceuticals wanted the warnings to be removed altogether. The agency said it decided to order Sprout to use the FDA’s preferred language when negotiations over the label change broke down.
When the FDA approved flibanserin for loss of libido in women, it came with a boxed warning about hypotension (low blood pressure) and syncope (fainting) in women taking the drug after drinking alcohol. The current label states, “Alcohol use is contraindicated.”
However, on Thursday, the FDA announced that post-marketing data has indicated that the risk of such adverse events is quite low “when at least two hours elapse between an alcoholic drink and taking the flibanserin pill.”
The FDA said the new label language would state, “Women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.”
Why did the FDA decide to keep the boxed warning? Because the agency had concerns about post-marketing trial data by Sprout, in which alcohol and flibanserin were taken simultaneously.
The drug regulatory body said, “There were missing or delayed measurements for blood pressure from when the women were first laying down to when they stood up that are critical in determining the risk of hypotension and syncope when taking Addyi and alcohol together.”
“The pattern of the missing or delayed measurements provides further evidence of an interaction between Addyi and alcohol that can increase the risk of hypotension and syncope. Given these results, the FDA has determined that the boxed warning and contraindication continue to be warranted,” the FDA added. The agency noted that Sprout has until April 16 to appeal the FDA’s order.
