FDA Orders Safety Labeling Changes for Female Sexual Dysfunction Therapy


The action requires the company to revise safety information that women and their health care professionals need when considering use of the drug.

The FDA today issued a safety labeling change order to Sprout Pharmaceuticals for their flibanserin drug product (Addyi). The action requires the company to revise safety information that women and their health care professionals need when considering use of the drug.

According to the agency, the changes are the result of the FDA’s review of postmarketing studies, including 1 required of Sprout when its flibanserin product was approved in August 2015, as well as other data. The drug is indicated to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

“The FDA helps ensure that the most current safety information about the use of prescription drugs is accurately reflected in product labeling, giving health care professionals and patients confidence that they are able to make the most informed treatment decisions,” said Julie Beitz, MD director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research’s Office of New Drugs, in a prepared statement. “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.”

At the time of approval, the FDA reviewed data that included several concerning cases of severe low blood pressure and passing out when flibanserin and alcohol were taken together. As a result, Sprout’s product labeling currently includes a boxed stating that alcohol must be avoided in women treated with flibanserin. The FDA also required a risk evaluation and mitigation strategy (REMS), requiring health care professionals who prescribe the drug and pharmacies that dispense it, must be certified with the REMS program for the product and that patients must be counseled about the risk of hypotension and syncope. In addition, the FDA required Sprout to further study the interaction between flibanserin and alcohol after approval.

Based on the results of postmarketing studies, the FDA has determined that changes must be made to Sprout’s labeling to clarify that there is still a concern about consuming alcohol close in time to taking flibanserin but that it does not have to be avoided completely. 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 2 hours before taking flibanserin at bedtime or to skip the drug’s dose that evening. Women should not consume alcohol at least until the morning after taking flibanserin at bedtime, according to the FDA.


FDA orders important safety labeling changes for Addyi [news release]. Silver Spring, MD; April 11, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635847.htm. Accessed April 11, 2019.

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