Overview
- The removal applies to more than 20 pills, patches and creams containing estrogen or progestin that are approved to treat menopausal symptoms.
- Updated FDA guidance advises initiating systemic therapy before age 60 or within ten years of menopause onset to reduce risk.
- Regulators will work with manufacturers to delete label references to cardiovascular disease, breast cancer and probable dementia while retaining an endometrial cancer warning for estrogen-only use.
- FDA Commissioner Marty Makary and some clinicians backed the change as evidence-based, while experts including Harvard’s JoAnn Manson cautioned that claims of broad long-term benefits remain unsettled.
- The FDA also approved the first U.S. generic version of Premarin to broaden access at lower cost, according to the reporting.