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FDA Launches Expert Review of Hormone Replacement Therapy Safety

Critics question its closed agenda following revelations of panelists’ ties to menopause treatment companies.

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Overview

  • The FDA convened a panel Thursday to reexamine HRT after decades of conflicting evidence over its safety and declining use.
  • FDA head Marty Makary, who has advocated for the therapy, cites potential benefits such as reduced Alzheimer’s risk and stronger bone and cardiovascular health when started early.
  • The agency’s existing warning label flags risks including endometrial and breast cancer and life-threatening blood clots, while an American Family Physician editorial warned against overmedicalizing menopause.
  • Several invited experts are affiliated with menopause treatment companies or the pharma-funded advocacy group 'Let's Talk Menopause,' prompting conflict-of-interest concerns.
  • The panel is set to consider proposals to revise or remove the current warning label on HRT products.