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FDA Reverses Decades-Old Warning on Hormone Therapy Products for Menopause

FDA ends decades-old warnings based on outdated studies, citing benefits like reduced heart disease and osteoporosis risk for menopausal women, boosting treatment access.

  • The FDA announced it will remove the "black box" warning labels from hormone replacement therapy products, claiming earlier fears about their safety were not supported by research.
  • Commissioner Dr. Marty Makary stated that earlier warnings about hormone replacement therapy linked to breast cancer were based on misrepresented data and created unnecessary fears.
  • Health Secretary Robert F. Kennedy Jr. emphasized that the decision reflects a need for evidence-based medicine and aims to empower patients.
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FDA to remove black box warning from hormone replacement therapy drugs

Blister packs of hormone replacement therapy medication. (Getty photos)WASHINGTON — The U.S. Food and Drug Administration announced Monday it plans to remove warnings from hormone replacement therapy drugs that can be used to address symptoms of menopause, saying the statements are no longer needed.  The black box warning, the strongest caution possible from the FDA, was added in the early 2000s after a study from the Women’s Health Initiative s…

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Ms. Magazine broke the news in on Monday, November 10, 2025.
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