Short answer
Partly, and product by product. In November 2025 the FDA asked makers to remove heart disease, breast cancer and probable dementia from the boxed warning on menopausal hormone therapy. The endometrial cancer warning stays on systemic estrogen-alone products. The first six updated labels were approved in February 2026; some labels still show the old warning.
What changed
On 10 November 2025 the FDA announced it was working with companies to remove references to cardiovascular disease, breast cancer and probable dementia from the boxed warning on menopausal hormone therapy. It also asked them to drop the old advice to use the lowest dose for the shortest time.
The labels gain a new line for systemic therapy: consider starting hormone therapy for moderate to severe hot flashes in women under 60, or within 10 years of menopause.
What did not change
The boxed warning about endometrial cancer stays on systemic estrogen-alone products, which warns about endometrial cancer with estrogen taken without a progestin in women who still have a uterus. Information about cardiovascular disease and breast cancer stays elsewhere in the label as warnings.
The FDA labeling notes that the large WHI trial tested specific oral products, so how its findings apply to other routes such as patches is not known.
Why your box may still look the same
Each product's label is updated separately. On 12 February 2026 the FDA approved the first six revised labels and said 29 companies had submitted changes. As of early October 2026, some widely used products on DailyMed still carry the older full boxed warning.
A shorter warning is not a green light for everyone. Your own history of clots, stroke, heart disease or breast cancer still shapes the decision. Educational content, not medical advice.
Related questions
Does this mean hormone therapy is now considered safe?
The FDA changed how the risks are presented, mainly for women under 60 or within 10 years of menopause. Risks still exist and still appear in the label's warnings section.
Does the change say anything about patches versus pills?
Not directly. For route and clot risk, see our page on whether the estrogen patch is safer than the pill, based on a 2026 BMJ study.
Read next
Sources
- FDA press announcement, 10 Nov 2025: removing misleading warnings on hormone replacement therapy
- FDA Drug Safety: labeling changes for menopausal hormone therapy (updated 12 Feb 2026)
- FDA press announcement, 12 Feb 2026: first labeling changes approved
- Makary et al., JAMA, 2026 (Updated Labeling for Menopausal Hormone Therapy)
Published 2026-10-03 · Last checked 2026-10-03
Educational content, not medical advice. Made for the United States.