FDA Begins Expert Review of Menopause Hormone Therapy Warnings

Overview

• FDA convened a 12-member expert panel on July 17 to reevaluate HRT risks and black box warnings.
• Panelists argued that early-2000s Women’s Health Initiative findings no longer apply to modern bioidentical hormone formulations.
• Experts highlighted evidence that HRT started within ten years of menopause onset can reduce fracture risk by up to 50% and lower dementia incidence.
• Critics have raised concerns over the panel’s lack of a public agenda and ties between some members and pharmaceutical-funded advocacy groups.
• The FDA plans to open a public docket in coming weeks for feedback before deciding on warning label revisions.