The NWHN’s Statement on the FDA Ordering Sprout Pharmaceuticals to Retain Black Box Label Warning Women Not Mix Addyi and Alcohol

The following statement can be attributed to Cynthia A. Pearson, Executive Director of the National Women’s Health Network.

Washington D.C. --  Yesterday the U.S. Food and Drug Administration ordered Sprout Pharmaceuticals to update the label of their female libido pill, flibanserin (brand name: Addyi). The label change says women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or skip the Addyi dose that evening, and that women should not consume alcohol at least until the morning after taking Addyi at bedtime.

The drug continues to carry a black box warning about potentially dangerous low blood pressure and fainting, especially when taken with alcohol. Patients taking the drug were previously told to completely avoid alcohol.

The changes recommended by the FDA were based on post-marketing studies by the company, which are required in some cases after approval of a drug. The NWHN believes that Sprout Pharmaceuticals has a duty to ensure that this new labeling information is visible and prominent in every place Addyi is prescribed, including third party telemedicine websites.

“Women should avoid Addyi because it is barely better than a placebo. If women do want to use Addyi, we encourage them to follow the FDA's advice about not drinking at least two hours beforehand and eight to ten hours afterwards” says Cindy Pearson, the Executive Director of the National Women’s Health Network.

The NWHN applauds the FDA for ensuring women get the safety information they need when deciding whether or not to take Addyi.

The National Women’s Health Network is supported by our members and by choice we do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.

Cindy Pearson has served as the NWHN’s Executive Director for 25 years. One of the most respected women’s health advocates in the country, she regularly testifies before Congress, the NIH, and the FDA. Cindy is often featured as a consumer expert on women’s health issues in news publications and for conferences and currently serves as President of the Board of Directors for Women’s Health Specialists.

Read more from Cindy Pearson.