The FDA Has Decided Not to Approve the Uterine Fibroid Drug, Esyma

Washington, D.C. — Esmya, a drug intended to treat uterine fibroids, was turned down by the U.S. Food and Drug Administration in a decision announced by Allergan, the U.S. sponsor. The NWHN applauds the FDA for this decision.

Women count on the FDA to make sure products are safe and there were very important safety concerns about using this drug. At least four cases of severe liver damage have been reported in European women, where the drug has been used for several years to control symptoms of fibroids.

Uterine fibroids are common, and can be problematic, interfering with work, quality of life and, in some cases, fertility. There are very few non-surgical options available to patients. As such, there has been a recent surge in development of new uterine fibroid medications designed to help patients manage and treat the condition.

NWHN has advocated for better treatments for fibroids for a long time, including drugs.  Hopefully drugs in the pipeline will be found to be both safe and effective.

We applaud the FDA for following the science.

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 was the NWHN’s Executive Director from 1996 to 2021. One of the nation's leading advocates for women's health, Cindy often testified before Congress,  NIH and the FDA and was frequently featured in the news as a consumer expert on women’s health issues. When she retired, Cindy received a Congressional Resolution in honor of her outstanding contributions to the health of women and girls.

Read more from Cindy Pearson.