Overview
- Boxed warnings for cardiovascular disease, breast cancer, stroke and probable dementia will be dropped, while a warning about endometrial cancer remains for systemic estrogen‑only products.
- The shift follows an FDA expert panel in July and a comprehensive evidence review, with manufacturers expected to update labels within months.
- Labels will add timing guidance, tailor safety information by product type, and remove the blanket directive to use the lowest dose for the shortest duration in favor of individualized decisions.
- The FDA also approved a generic version of Premarin and a nonhormonal therapy for vasomotor symptoms such as hot flashes.
- Major specialty groups, including ACOG, praised clearer, product‑specific guidance but urged caution with systemic therapies, as critics warned that less prominent warnings could undercommunicate real risks.