Overview
- A boxed warning for endometrial cancer remains on systemic estrogen‑only products, while labels will be updated to describe cardiovascular, breast cancer and dementia risks.
- New guidance advises starting systemic therapy before age 60 or within 10 years of menopause onset when benefits may outweigh risks.
- The decision draws on literature assessments and expert reanalyses focusing on women who initiated treatment closer to menopause.
- Clinicians say the change should ease stigma and prompt more informed discussions, though prescribing will remain individualized.
- Package inserts will continue to detail potential harms, and experts note nonhormonal options remain available.