FDA Modifies Alcohol Warning for Addyi, So-Called 'Female Viagra'

Alcohol consumption is no longer a strict contraindication for the use of flibanserin (Addyi, Sprout Pharmaceuticals) to treat women who have hypoactive sexual desire disorder (HSDD), according to the latest information from the US Food and Drug Administration (FDA).

Although there is still a concern about consuming alcohol shortly before taking flibanserin, there is no need to avoid alcohol completely, the FDA said in a statement released April 11.

Instead, women should discontinue drinking alcohol at least 2 hours before taking the drug at bedtime or skip the dose that evening. In addition, after taking flibanserin at bedtime, women should not consume alcohol any sooner than the following morning. This revised safety information will be added to the drug's label.

Known as the "female Viagra," flibanserin is a 5-hydroxytryptophan (1A) (5-HT[1A]) receptor agonist and 5-HT(2A) receptor antagonist. It was approved in the United States in 2015 to treat acquired, generalized HSDD in premenopausal women, a disorder that affects an estimated 10% of women. Flibanserin is taken once daily at bedtime.

Checkered Past Still Not Completely Resolved by Postmarketing Studies

The FDA rejected flibanserin twice before approving it. The rejections were based on the occurrence of several cases of severe hypotension and syncope when flibanserin and alcohol were taken together. When the drug was finally cleared for marketing, the FDA required that it carry a boxed warning stating that alcohol must be avoided by women who use it.

The FDA also required a risk evaluation and mitigation strategy that requires that healthcare providers who prescribe flibanserin and pharmacies that dispense it be certified with the program and that women be counseled about the risk for hypotension and syncope.

Last month, on the basis of results of postmarketing studies, the manufacturer asked the FDA to completely remove from the product labeling the boxed warning as well as the use of alcohol as a contraindication.

But on the basis of their review of the studies and other available data, the FDA concluded that removing the alcohol contraindication is "not acceptable for the protection of public health."

Therefore, the boxed warning and the sections of the product's label concerning contraindications, warnings and precautions, and adverse reactions will be updated to reflect the new advice (ie, that patients stop drinking alcohol at least 2 hours before taking flibanserin at bedtime or that they skip the dose that evening; and that after taking the bedtime dose, patients avoid drinking alcohol at least until morning).

The FDA has ordered the company to make the label changes because the agency was not able to reach an agreement with the company, which was continuing to request removal of the boxed warning and contraindications about alcohol completely.

In the FDA-required postmarketing trial involving women who took flibanserin and who drank alcohol at the same time, blood pressure measurements taken from the time the patients first lay down until they stood up were "missing or delayed." These measurements are critical in determining the risk for hypotension and syncope when the drug is taken with alcohol, the agency said.

"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," it explained.

"Women at home will not have the safety measures that were included in this trial or necessarily have access to immediate assistance if they were to experience severe hypotension or syncope, which can lead to serious outcomes including falls, accidents and bodily harm," FDA noted.

On the other hand, other postmarketing data show that the risk for severe hypotension and syncope is reduced when women who consume up to two alcoholic drinks wait at least 2 hours before taking flibanserin, the FDA said.

These results are "sufficient" to support a modification to the boxed warning and contraindication.

Women should also be advised to discontinue treatment after 8 weeks if they do not see an improvement in sexual desire and associated distress, the FDA stressed.

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