US FDA moves to drop broad boxed warnings on menopause hormone therapy
2025-11-10
On 10 November 2025, the US Food and Drug Administration said it would remove the broad boxed warnings about heart disease, breast cancer and dementia from menopause hormone therapy labels. The change makes the labels better reflect newer evidence, but it does not make hormone therapy risk-free or right for everyone.
Talk to a doctor before starting, stopping or changing hormone therapy, and get prompt care for unusual vaginal bleeding, chest pain, sudden leg swelling or new breast lumps while using it.
What happened
The US Department of Health and Human Services announced that the FDA would start removing the “black box” warnings from menopausal hormone therapy products.1 These boxed warnings had been on US labels since 2003.4
The FDA asked companies to take out wording about risks of cardiovascular disease, breast cancer and probable dementia.1,2 One boxed warning stays: the endometrial (womb lining) cancer warning on systemic estrogen-alone products.1
The process takes time. On 12 February 2026, the FDA approved the first six updated labels, covering pills, gels and a vaginal ring. By then, 29 manufacturers had sent in proposed changes.3
Why the FDA made the change
The old warnings were based mainly on the Women's Health Initiative (WHI) trial from the early 2000s. The average woman in that trial was 63, more than a decade past the usual age of menopause.1
The FDA said newer research shows a better balance of benefit and risk for some women.1,2 This applies to women who start before 60 or within 10 years of menopause.1 The new labels will recommend starting systemic therapy in that window.1
On the same day, the FDA also announced approval of a generic version of conjugated estrogens and a new non-hormonal option for hot flashes.1
How experts reacted
The Menopause Society welcomed the removal of the warning on low-dose vaginal estrogen. It said the warning may have put women off a safe and effective treatment. It also stressed that systemic estrogen still carries risks for some women, especially older women.5
The European Menopause and Andropause Society (EMAS) also supported the decision. It warned against swinging to the other extreme and said the goal is appropriate prescribing, not maximal prescribing.6 The Australasian Menopause Society said the risks had been overstated, but noted there is little long-term safety data for modern products.4
Some US experts were more cautious. They said parts of the FDA messaging went beyond the evidence, for example on heart disease and memory.7 One expert noted there is no randomized trial evidence that hormone therapy prevents heart disease or memory decline.7
Others worried that social media may now overstate the benefits. They warned against a return to the idea of estrogen as a “fountain of youth.”7
What has not changed
The science on risk did not change overnight. What changed is how the label presents it. The first updated labels removed boxed wording, but they still describe the product's risks and uses.3
The endometrial cancer warning remains on systemic estrogen-alone products.1 This is why women who still have a womb are usually prescribed a progestogen alongside systemic estrogen.
Decisions about when to start and how long to continue are still made between you and your prescriber.1 The Menopause Society says this should include a review of your health, family history, symptoms and preferences.5
What it means for you, and what it does not
For many healthy women in their 40s and 50s with troublesome symptoms, hormone therapy is a reasonable option to discuss. The label change may make that conversation easier.
It does not mean hormone therapy has no risks. Risks depend on your age, health history and the type of product.5,6 It also does not mean hormone therapy should be used to prevent heart disease or dementia. EMAS says it is not indicated for either.6
The change applies to US labels. Product information in other countries is set by local regulators and may differ.4 For a full overview, see our page on hormone therapy.
Related
Sources
- HHS advances women's health, removes misleading FDA warnings on hormone replacement therapy, US Department of Health and Human Services (2025)
- FDA removes black boxed warning from hormone therapies for menopause, Pharmacy Times (2025)
- FDA approves label changes for first batch of menopausal hormone therapy products, Urology Times (2026)
- Australian menopause experts support change in hormone therapy warnings, Australasian Menopause Society (2025)
- The Menopause Society comments on the FDA announcement on hormone therapy, The Menopause Society (2025)
- EMAS statement on the FDA decision to remove black box warnings from menopausal hormone therapy, European Menopause and Andropause Society (2025)
- HHS revises hormone therapy black box warning for menopause treatment (Healio report), National Center for Health Research (2025)