Flibanserin (Addyi) Issued Label Change

April 12, 2019

Safety alert issued requiring warning about concurrent alcohol use.

The FDA is requiring a safety labeling change order for flibanserin (Addyi, Sprout) to strengthen and clarify information about alcohol use while taking the product. Addyi already had a boxed warning in its labeling about the increased risk of hypotension and fainting if taken with alcohol.

The FDA is ordering the safety labeling change requiring Sprout to make these changes because the agency was not able to reach an agreement with the company, which was requesting the removal of the boxed warning and contraindication about alcohol completely. The FDA determined that removing the boxed warning and contraindication was not acceptable for the protection of public health.

Flibanserin was approved in August 2015 to treat acquired generalized hypoactive sexual desire disorder in premenopausal women. “We recognize that women want access to treatments for female sexual dysfunction, and we are committed to helping ensure approved therapies are safe and effective when taken as indicated and to supporting the development of new therapeutic options for female sexual dysfunction,” says Julie Beitz, MD, FDA’s director of the Office of Drug Evaluation III in the Center for Drug Evaluation and Research’s Office of New Drugs.

Based on postmarketing studies, the FDA has determined that changes must be made to Addyi’s labeling to clarify that there is still a concern about consuming alcohol close to the time a dose of Addyi is taken. Alcohol does not have to be avoided completely, however, according to an FDA statement. “Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect 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 FDA states.

Because of the risk of hypotension and fainting, the FDA required that health care professionals who prescribe Addyi and pharmacies that dispense Addyi, must be certified with the Addyi REMS program and that patients must be counseled about the risks. In addition, the FDA required Sprout to further study the interaction between Addyi and alcohol after it was approved.

Addyi is available through websites like Hers, which will sell the product subject to an online consultation with a physician. The web page does not mention the contraindication of alcohol use. The official Sprout website for Addyi has the safety information about hypotension, fainting, and alcohol, and the full prescribing information, but also has a link to a telemedicine service that allows consumers to speak with a doctor by phone to get a prescription.

“We are taking this action because it is our responsibility to help protect the safety of those who take prescription medicines, which includes helping to ensure that patients are provided access to the most up-to-date information about the drugs they take,” says FDA’s Beitz.

Full Prescribing Information