FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes

The FDA Office of Women's Health, in collaboration with the Center for Drug Evaluation and Research (CDER), presents this continuing education webinar on menopausal hormone therapy (MHT) labeling — what has changed, why it changed, and what it means for patients and providers. In this presentation, FDA medical experts walk through the full history of menopausal hormone therapy regulation, the design and findings of the landmark Women's Health Initiative (WHI) trials, and the eight key recent changes to FDA-approved MHT prescribing information labels. What You Will Learn: The history of menopausal hormone therapy use and regulation, from the 1890s to today The symptoms MHT is designed to treat, including vasomotor symptoms (VMS) and genitourinary syndrome of menopause (GSM) The design, objectives, and findings of the Women's Health Initiative (WHI) trials Why the WHI trials were stopped early and what the results meant for MHT use How and why MHT use declined more than 70% following the 2002 WHI publication The eight key recent changes to MHT prescribing information labels, including changes to boxed warnings for breast cancer, cardiovascular disease, dementia, and endometrial cancer How age-of-use considerations are now reflected in updated MHT labels What the updated labels mean for the four MHT drug classes: systemic estrogen plus progestogen (EP), systemic estrogen alone (E Alone), topical vaginal estrogen (E Alone Topical), and progestogen alone (P Alone)