FDA

FDA moves to revise menopausal hormone therapy labels, easing longstanding warnings

November 13, 2025

FDA has requested labeling changes for menopausal hormone therapies (MHT), aiming to clarify benefit-risk considerations and remove boxed warnings about cardiovascular disease, breast cancer, and probable dementia. According to an FDA press release, these changes follow a comprehensive review of scientific literature and public input, acknowledging that prior warnings were based on older studies with limitations. MHT remains indicated for vasomotor symptoms, genitourinary syndrome of menopause, and osteoporosis prevention. The agency emphasizes individualized decision-making between clinicians and patients to ensure evidence-based care.

Source:

FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies. [News release]. 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations