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FDA Announces Removal of Black Box Warning on Low-Dose Vaginal Estrogen
On November 10, 2025, the U.S. Food and Drug Administration (FDA) announced the removal of the black box warning on Estrogen Therapy. This change reflects the latest scientific evidence supporting the safety and benefits of estrogen use for appropriate patients and marks a significant step forward for women’s health.
The American Urological Association is proud to have played an active role in this process over the past several years. AUA maintains that low-dose vaginal estrogen is a safe and effective treatment for certain menopause-related conditions. In addition to covering this topic at the most recent Annual Urology Advocacy Summit, in September 2025, the AUA sent a letter to the FDA in support of removing the outdated warning label on estrogen products and AUA members testified at the hearing on this issue.
In April 2025, in partnership with Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) and American Urogynecologic Society (AUGS), the AUA released its clinical guideline on the Genitourinary Syndrome of Menopause (GSM), which includes evidence-based guidance on hormonal and non-hormonal treatment options, including local, low-dose vaginal estrogen. The AUA is grateful to our guidelines panel and AUA members such as Dr. Rachel Rubin and Dr. Kelly Casperson, who have been champions in this space and whose work has led to this landmark shift in the way we treat GSM in this country.
The AUA applauds the Department of Health and Human Services (HHS) and FDA for its evidence-based decision to remove the black box warning. We are thrilled about this advancement for women’s health.