FDA orders important safety labeling changes for Addyi

The U.S. Food and Drug Administration today issued a safety labeling change orderto Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the drug. The changes are the result of the FDA’s review of postmarketing studies, including one required of Sprout when Addyi was approved in August 2015, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, as well as other data. “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, M.D. director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research’s Office of New Drugs. “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 hypotension (low blood pressure) and syncope (passing out) when Addyi and alcohol were taken together. As a result, Addyi’s labeling currently includes a boxed warning (the strongest warning the FDA requires), which states that alcohol must be avoided in women treated with Addyi. The FDA also required a risk evaluation and mitigation strategy (REMS), which requires 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 risk of hypotension and syncope. In addition, the FDA required Sprout to further study the interaction between Addyi and alcohol after approval.