Overview
- Federal officials said the prior warnings were based on outdated interpretations of early‑2000s research and had discouraged many eligible patients from using HRT.
- The FDA will remove blanket label references to cardiovascular disease, breast cancer and probable dementia risks, while detailed safety information remains in package inserts.
- Clinician groups welcomed the shift as enabling shared decision‑making, noting that risks vary by age, timing since menopause, formulation and route of administration.
- Experts cautioned that hormone therapy has not been proven to prevent heart disease or dementia, urging individualized counseling and consideration of nonhormonal options.
- HRT use fell to roughly 5% of postmenopausal women after the WHI era, and systemic therapy remains inappropriate for breast cancer survivors and many with prior clots, heart attack or stroke.