Overview
- The action applies to estrogen- and progestogen-containing products prescribed for menopausal symptoms and to lower fracture risk.
- Revised labels will drop references to cardiovascular disease, breast cancer and probable dementia risks, while a boxed warning for endometrial cancer remains on systemic estrogen-alone products.
- The FDA now advises considering systemic therapy before age 60 or within 10 years of menopause onset, noting potential cognitive and cardiovascular benefits when started earlier.
- Federal leaders attribute the prior warnings to early 2000s WHI-era findings that discouraged use, contributing to a long decline in hormone therapy adoption to roughly 5% of postmenopausal women.
- ACOG and practicing clinicians welcomed the move as a boost to shared decision-making, with the FDA stressing that detailed risk information stays in inserts and treatment should be individualized.