FDA Panel Reviews Hormone Therapy Warning Labels

The FDA has convened an expert panel to reassess the safety and efficacy of menopausal hormone therapy (MHT), partly in response to concerns raised by the 2002 Women’s Health Initiative that linked MHT to increased health risks. Recent evidence suggests MHT may be safe and beneficial for women under 60 or within 10 years of menopause, especially those without a history of breast cancer or cardiovascular disease. FDA Commissioner Dr. Marty Makary has argued that earlier warnings may have overstated risks, discouraging use of a therapy that can improve quality of life and reduce risks such as osteoporosis and cognitive decline. The panel is considering potential label changes, including whether current boxed warnings accurately reflect differences between vaginal and systemic therapies. Some experts support updating or removing certain warnings for low-risk women, while emphasizing the importance of individualized risk assessment. The FDA aims to ensure that both patients and providers receive balanced, evidence-based information to guide menopause management.