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FDA Begins Expert Review of Menopause Hormone Therapy Warnings

It is reassessing boxed warnings on estrogen products to match updated data on benefits like bone and brain health.

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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.