Overview
- The FDA and HHS have initiated label changes to lift broad boxed warnings from many estrogen-containing treatments for menopausal symptoms.
- Updated labels will drop references to cardiovascular disease, breast cancer and probable dementia risks, with the FDA directing manufacturers on revised language.
- A boxed warning for endometrial cancer will remain for systemic estrogen‑only products.
- ACOG leaders and practicing OB-GYNs welcomed the move as enabling shared decision-making, with some clinicians preferring transdermal patches due to lower clot risk than oral estrogen.
- HHS points to a long decline in use to roughly 5% after the Women’s Health Initiative and underscores benefits when therapy begins within about 10 years of menopause.