On November 10, 2025, the FDA announced it will remove black box warnings from hormone therapy products used to treat menopausal symptoms, including combined estrogen-progestogen, estrogen-only, and progestogen-only treatments1234.
The black box warning—mandated since 2003—highlighted risks of breast cancer, stroke, and cardiovascular disease based primarily on findings from the Women’s Health Initiative (WHI) study in postmenopausal women21.
The FDA's decision reflects a comprehensive review of new scientific literature, drug use data, and public input, concluding that the balance of benefit and risk varies by age, product formulation, and clinical indication12.
Label changes will eliminate the broad warnings about cancer and cardiovascular disease and instead provide nuanced, evidence-based language to guide use, especially in younger women with significant symptoms12.
FDA officials indicated that removing the warning aims to reduce stigma, clarify true risks, and likely encourage more women to seek treatment for menopausal and perimenopausal symptoms56.
This is considered a major policy reversal and is expected to expand access to hormone therapies as a treatment for menopausal symptoms345.
Sources:
1. https://www.contemporaryobgyn.net/view/fda-initiates-removal-of-boxed-warnings-from-hormone-therapy-for-menopause
2. https://www.statnews.com/2025/11/10/fda-reverses-hormone-warning-menopause-health/
3. https://www.healthonecares.com/about-us/newsroom/fda-no-longer-requiring-significant-warning-label-with-hormone-therapies-for-menopause
4. https://www.fiercehealthcare.com/regulatory/fda-rolls-back-warning-labels-hrt-products-menopause
5. https://www.cbsnews.com/video/why-warning-labels-on-some-menopause-hormone-therapies-are-being-removed/