November 10, 2025

Statement from the Menopause Advocacy Working Group

We applaud and support the FDA’s decision to remove the boxed warning for local vaginal estrogen used to treat menopause-related vaginal and urinary symptoms. Despite decades of evidence demonstrating its safety and minimal absorption, the previous warning prevented many women from using it and clinicians from prescribing this highly effective therapy for the treatment of Genitourinary Syndrome of Menopause (GSM) and its removal is a major step forward for women’s health.

Regarding removal of the boxed warning for systemic hormone therapy, which is much more absorbed, benefits and risks need to be assessed on an individual basis. We encourage all women to have thorough discussions with their healthcare providers before initiating treatment and on an ongoing basis. Systemic treatment requires individualized care based on a woman’s complete medical history. The Menopause Society provides detailed, evidence-based guidelines on the use of systemic therapy, including considerations of age at initiation, dose, route (oral or transdermal), duration, and need for uterine protection.

More than 26,000 members of our community—including healthcare professionals and the general public—have joined us in advocating for this important change. This decision aligns with the latest evidence-based research and helps eliminate the unnecessary fear that this warning has long perpetuated.

This achievement underscores the importance of research-backed advocacy and patient education. Our Menopause Advocacy Working Group—comprising leading experts and passionate advocates—will continue advancing women’s health by expanding access, strengthening support, and driving meaningful change nationwide.

Sincerely,
The Menopause Advocacy Working Group