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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307 Articles
Menopause hormone therapy no longer has the FDA’s most-dire warning. Now what?
Removing the most dire warning from hormonal therapies to treat menopause is likely the right call, women’s health experts in Colorado say, but exuberance for the treatments could be getting ahead of the evidence. Since 2003, the U.S. Food and Drug Administration required a “black box” warning — reserved for the most-serious side effects — on products that use estrogen, progesterone or both to treat symptoms such as hot flashes and vaginal dryne…
FDA makes major move on women’s health: What is changing?
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced Monday it will begin removing “black box” warnings from hormone replacement therapy (HRT) products used to treat menopause symptoms.
FDA reverses policy, removes black box labels for hormonal menopause drugs
The Food and Drug Administration (FDA) announced Monday that it will remove black box warning labels from hormone replacement therapies (HRT) used to ease symptoms of menopause. Black box warning labels are the strongest safety warning the agency can give a medication and highlight serious health risks. Warnings removed Since 2003, the agency has required HRTs to carry black box labels warning users of an increased risk of heart attack, stroke,…
Menopause hormone therapy treatments sheds its warning label. Here's what it means.
The warning label has appeared on hormone therapy treatments for nearly two decades, after a landmark study found the therapy could increase risks of cancer. Now the FDA is changing course.
Conservative Review
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‘He just said it anyway’
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