Removal of boxed warning for menopausal hormone therapy

ABSTRACT: In November 2025, the Food and Drug Administration removed the boxed warning from menopausal hormone therapy products, marking a significant shift in how clinicians and patients understand the risk-benefit profile of these widely used medications. This change reflects 20 years of evolving evidence since the Women's Health Initiative study and has important implications for nursing practice. This article reviews the evidence behind this regulatory change, clarifies current indications and contraindications for hormone therapy, and provides practical guidance for nurses counseling patients about menopause management options.