FDA Removes Boxed Warning From Menopausal Hormone Therapy
This narrative review explains the November 2025 FDA decision to remove the boxed warning from menopausal hormone therapy and reframes counseling around timing, patient selection, and individualized risk assessment.
📅 Journal publication: Oct 1, 2026(online Sep 21, 2026)·Last updated: Oct 6, 2026
★ Editor's Pickmenopausal hormone therapyestrogenprogestogenmedroxyprogesterone acetatevaginal estrogentransdermal estrogenmenopauseboxed warningFDAWomen's Health Initiativenarrative reviewwomen's healthWomen's Health / Reproductive
Background Information
FDA removes boxed warning from menopausal hormone therapy, changing safety perceptions.
The removal of the boxed warning on menopausal hormone therapy highlights the evolution in understanding its safety profile, impacting prescribing practices and patient counseling. The FDA decision reflects two decades of evidence showing a revised risk-benefit appraisal of menopausal hormone therapy. Nurses and healthcare providers must update counseling and prescribing practices in light of the removal of the warning, incorporating new evidence into patient discussions. The boxed warning removal signifies updated safety views on menopausal hormone therapy.
📊 Deep Analysis Available
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Citation:Dang M Removal of boxed warning for menopausal hormone therapy: What nurses need to know. Nursing. 2026;56(10):34-38. doi:10.1097/NSG.0000000000000411
Subscribers receive access to a complete clinical analysis, available online and as a downloadable PDF.
Executive Summary
Study Design
Patient Population
Primary Outcomes
Secondary Outcomes & Safety Profile
Pharmacist Implications
Clinical Pearls
Limitations
Controversies & Evidence Gaps
Cost & Logistics
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