University of Central Florida

FDA Expert Panel Calls for Revision of Menopausal Hormone Therapy Warning Labels

- An FDA expert panel convened to reassess boxed warnings for menopausal hormone therapy, with multiple experts arguing that current labels overstate risks and are not supported by comprehensive scientific evidence. - Panel members presented data showing that vaginal estrogen products carry significantly different safety profiles than systemic hormone therapy, yet both carry identical boxed warnings due to class labeling regulations. - Experts highlighted critical gaps in medical education, noting that only 31.3% of U.S. residency programs have standardized menopause training, contributing to underutilization of beneficial therapies. - The panel emphasized that reanalysis of Women's Health Initiative data shows favorable outcomes for women aged 50-59 years, with estrogen alone linked to reduced breast cancer incidence and mortality over long-term follow-up.