SHE+ Foundation Statement on the Removal of the FDA Black Box Warning on Low-Dose Vaginal Estrogen & Menopause Hormone Therapies

Last week, the United States Department of Health and Human Services livestreamed a pivotal, life-changing announcement: they will be removing the outdated black-box warning that appears on all hormone therapy products, including low-dose vaginal estrogen and menopause hormone therapies, to instead adopt labeling that more accurately reflects current evidence and clinic practice. 

By updating the labeling it is a signal that women’s menopausal, perimenopausal, and post-menopausal health, including their sexual health and urinary health, are legitimate, evidence-based areas of care, worthy of the same accuracy and respect we give other treatments. 

Redefining the boxed warning is a critical step toward ensuring that women receive accurate information, timely access to effective therapies, and are empowered in their health decisions. 

The SHE+ Foundation endorses the following statements by ACOG and The Menopause Society. 

Statement from ACOG (American College of Obstetricians and Gynecologists)

Statement from The Menopause Society