11/10/2025
This morning announced that the Food and Drug Administration (FDA) would remove the black box warning on hormone replacement therapy (HRT) products - a very important and positive first step to addressing access to therapies for women suffering from menopausal symptoms.
Vaginal estrogen products are safe and effective for most women. Clinicians, scientists, and women's health advocates have been working for two decades to correct the mislabeling of vaginal estrogen with the black box warning (reserved for treatments that pose the most serious and life-threatening side effects). Most recently the "Unboxing Menopause" campaign generated tens of thousands of letters of support from women across the country.
Systemic hormone therapy requires a nuanced approach and women should discuss their personal risks and benefits with a qualified healthcare professional.
The is committed to continuing to work with medical societies, women's health advocates, and policy leaders to ensure that all women and healthcare professionals understand how to use available hormonal and non-hormonal therapies safely and effectively to help women manage their menopausal symptoms, improve their overall health, and thrive during the menopausal transition and beyond.
We're grateful to Rachel S. Rubin MD - Urologist and Sexual Medicine Specialist and Kelly Casperson, MD You Are Not Broken for helping to share the significance and importance of various hormonal therapies at the event this morning.
Thanks to ALL the women's health clinicians, scientists, experts, and advocates who have worked so diligently to remove barriers to women having access to the information and treatments that can improve their lives.
It was great to see such broad representation at today's meeting from so many medical disciplines, advocacy organizations, women's health leaders, and other partners. There are too many to tag here, but we know this important work will continue and we look forward to it!
Bone Health and Osteoporosis Foundation
Society for Women's Health Research
Let's Talk Menopauseadvocates
HealthyWomenenorg
