Menopause Hormone Therapy: What Changed

At a glance

What did FDA change?: Removed cardiovascular disease, breast cancer and probable dementia from the boxed warning on approved products as labels are updated When?: Announced November 2025; first six approvals February 12, 2026 Which products so far?: Prometrium, Divigel, Cenestin, Enjuvia, Estring and Bijuva (FDA list current as of 02/12/2026); 29 companies have submitted changes What's still boxed?: Endometrial cancer, on systemic estrogen-alone products Who benefits most?: Per FDA and HHS, women who start within 10 years of menopause onset or before about 60 What does it treat?: Hot flashes, night sweats, vaginal dryness and painful sex; it also helps prevent bone loss What isn't it for?: Preventing heart disease. Its effect on dementia is unknown

Why the old warning existed

The boxed warning traced back to the Women's Health Initiative (WHI) trials, which were stopped in 2002 and 2004. HHS's Office on Women's Health notes that the average participant was 63 and that the trials tested specific products (conjugated equine estrogens with or without medroxyprogesterone acetate). Many women who came after were steered away from hormone therapy, including younger women closer to menopause.

What FDA changed

FDA asked makers of menopausal hormone therapy to update their labels. Under the changes:

- Risk statements about **cardiovascular disease, breast cancer and probable dementia** come out of the boxed warning. - The **endometrial cancer** boxed warning stays for systemic estrogen-alone products. - Heart disease and breast cancer risks are still described in other parts of the label.

FDA said women who start hormone therapy within 10 years of menopause onset (generally before 60) had reduced all-cause mortality and fewer fractures in the evidence it reviewed. FDA also noted that in 2020 about 41 million U.S. women were ages 45 to 64, while only about 2 million women ages 46 to 65 got a hormone therapy prescription.

Which products have updated labels?

FDA's list, current as of February 12, 2026, shows approved changes for:

- **Prometrium** (progesterone) - **Divigel, Cenestin and Enjuvia** (systemic estrogen alone) - **Estring** (vaginal estrogen) - **Bijuva** (systemic estrogen plus progesterone)

Other manufacturers have submitted changes that FDA is reviewing. Ask your doctor or pharmacist whether your product's label has been updated.

Who is hormone therapy for?

HHS says hormone therapy can treat hot flashes and night sweats, vaginal dryness and pain during sex, and helps prevent bone loss. Benefits are more likely to outweigh risks when therapy starts before age 60 or within 10 years of menopause.

Who should usually avoid it?

HHS says hormone therapy is usually not recommended if you have:

- Unexplained vaginal bleeding - Breast cancer that's hormone-receptor positive - A current or recent blood clot - A history of stroke or heart attack - Liver disease

Questions to ask your doctor

- Am I a good candidate given my age, time since menopause and health history? - Which type fits me: estrogen alone, estrogen plus progestogen, or a local vaginal product? - Has my product's label been updated? - What risks still apply to me, and how often should we reassess? - What are non-hormonal options if hormones aren't right for me?

Sources and disclaimer

Sources: - U.S. Food and Drug Administration, "FDA Approves Labeling Changes to Menopausal Hormone Therapy Products" (Feb. 12, 2026), fda.gov, fetched Oct. 29, 2026 - U.S. Food and Drug Administration, "Menopausal Hormone Therapies with Updated Prescribing Information" (current as of 02/12/2026), fda.gov, fetched Oct. 29, 2026 - HHS Office on Women's Health, "Hormone therapy safety" (womenshealth.gov, last updated Oct. 23, 2026), fetched Oct. 29, 2026

This guide is general information, not medical advice. Talk to your doctor before starting or stopping any medicine.