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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FDA head on dropping warnings from menopause hormone therapy
The FDA announced it would begin asking drug companies to remove so-called “black box” warnings for hormones prescribed to treat symptoms of menopause. The FDA says the warning has dissuaded generations of women from taking advantage of the medication that could help them. Ali Rogin discussed more with FDA Commissioner Dr. Marty Makary.
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 to Remove ‘Black Box’ Warnings from Hormone Replacement Therapy.
PULSE POINTSWHAT HAPPENED: The U.S. Food and Drug Administration (FDA) announced the removal of “black box” warnings from over 20 hormone replacement therapy products used for menopause symptoms.WHO WAS INVOLVED: Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, and the American College of Obstetricians & Gynecologists.WHEN & WHERE: The announcement was made Monday, with updates to drug labels now un…
FDA to address hormone therapy drug label concerns
The FDA says warning labels on some hormone therapy drugs have deterred women who might benefit from receiving menopause treatment. Now, the agency is taking steps it says will make the medicines more accessible. FOX News reporter Mike Emanuel has more.
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