WASHINGTON -- Drinking alcohol with the female libido booster flibanserin (Addyi) appears somewhat less dangerous than initially thought and the to reflect the new data -- over the manufacturer's objection.
Drugmaker Sprout Pharmaceuticals wanted the warnings removed altogether, the agency explained. When negotiations over the label change broke down, the FDA said it decided to order Sprout to use the agency's preferred language.
When flibanserin was approved, it came with a in women taking the drug after drinking alcohol, which had been seen in the product's clinical trials. "Alcohol use is contraindicated," the current label states flatly.
But according to the , post-marketing data indicate that risk of such events is low when at least two hours elapse between an alcoholic drink and taking the flibanserin pill.
Consequently, the new label language will state that "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," the announcement said.
One reason the FDA decided to keep the boxed warning was that the agency had concerns about Sprout's post-marketing trial data, in which alcohol and flibanserin were administered simultaneously.
"[T]here 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 agency said. Moreover, the missing or delayed measurements were primarily in women who took the drug and alcohol together, rather than in the control groups that received one or the other.
"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 agency said.
Sprout has until April 16 to appeal the order, the FDA noted.
Flibanserin has been controversial since long before its 2015 approval. Questions were raised about whether the condition it's intended to treat -- hypoactive sexual desire disorder -- actually merits drug therapy. The drug's efficacy was modest at best in the clinical trials, and critics seized on the hypotension/syncope incidents to argue that the benefit-risk balance was unfavorable.
Shortly after the drug was approved, Valeant Pharmaceuticals bought Sprout for $1 billion and took over flibanserin's marketing. But sales were weak and Valeant eventually gave Sprout, and flibanserin, back to Sprout's original owners (, according to Fortune).