Overview
- The agency asked manufacturers to strip black box cautions from many estrogen-containing products, reversing two decades of labeling tied to the Women’s Health Initiative.
- A boxed warning about endometrial cancer will remain on systemic estrogen‑alone formulations such as pills, patches and gels.
- Guidance centers on use for people younger than about 60 or within 10 years of menopause, with risk profiles differing between systemic and low‑dose vaginal options.
- Medical groups including ACOG welcomed the change and urged product‑specific counseling, while independent experts cautioned that risks persist and evidence of broad long‑term benefits is uncertain.
- The FDA also approved a generic Premarin and a nonhormonal therapy for hot flashes, expanding treatment choices.