US EditionFDA Reverses Decades-Old Warning on Hormone Therapy Products for Menopause
- On Nov. 10, the U.S. Food and Drug Administration announced it will remove boxed warnings from all hormone replacement therapies, a change presented by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary.
- The 2002 Women’s Health Initiative trial was halted early after links to higher stroke, blood clot and breast cancer rates, prompting caution and a boxed warning that reduced hormone therapy prescriptions for more than 20 years.
- The FDA convened an expert panel in July to review evidence, and officials say the decision followed a comprehensive literature review and public input, while recent analyses found fewer risks for early hormone therapy users.
- Alongside the announcement, the FDA approved a newly approved generic Premarin and a non-hormonal therapy for hot flashes, while updating prescribing information with lower boxed warnings and guidance to start treatment in women younger than age 60 or within 10 years of onset of menopause.
- Advocates say the move could change care for millions because more than 40% of U.S. women are in perimenopause or beyond, and hormone therapy use fell from about 40% to about 5%.
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209 Articles
Tioga Publishing
US to remove warnings from menopause hormone therapy
The United States will remove strong safety warnings on many hormone therapies used to alleviate menopausal symptoms, saying the risks have been exaggerated, authorities announced Monday.
Trump Administration Ends 20 Years of 'Misinformation' — HHS Lifts Misleading Black Box Warnings on Hormone Replacement Therapy to Help Women Through Menopause | The Gateway Pundit | by Jim Hᴏft
The Trump Administration has officially moved to end two decades of fear-driven misinformation about hormone replacement therapy (HRT).
FDA pulls warning labels from hormone replacement therapies
Hormone replacement therapies used to treat menopause symptoms no longer need to carry strict warnings about potential side effects, including cancer and heart disease, the Food and Drug Administration announced Monday.
Chicago Tribune
FDA removes long-standing warning from hormone-based menopause drugs
WASHINGTON — Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the Food and Drug Administration announced Monday. U.S. health officials said they will remove the boxed warning from more than 20 pills, patches and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms like…
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