US EditionFDA Reverses Decades-Old Warning on Hormone Therapy Products for Menopause
FDA updates labeling to reflect nuanced risks of hormone therapy, supporting shared decision-making and potentially benefiting millions deterred by outdated warnings.
- 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%.
313 Articles
313 Articles
Hubkova: Hormone therapy makes a comeback – finally
For more than 20 years, women entering menopause were told to be afraid of hormone replacement therapy. Headlines warned of higher risks for heart attacks, strokes, blood clots, dementia, and breast cancer. Usage dropped from nearly one-third of menopausal women in 1999 to under 5 percent by 2022. As a result, many women endured hot flashes, poor sleep, mood shifts, and long-term risks like osteoporosis and heart disease — all driven by fears we…
How a generation of women was misled about hormone therapy
"Was I misled?" That's the question I hear most from my patients lately — asked with anger, exhaustion, and the quiet devastation of women who wonder if they lost years of their lives to menopause symptoms they were told were untreatable. The answer came earlier this month when the U.S. Food and Drug Administration announced it would remove "black box" warnings from hormone therapy products after 23 years. For many women, the reversal is an admi…
The Trouble With “Follow the Science”
Scientific guidance isn’t carved in stone—it shifts as new evidence reshapes old assumptions. The recent reversal of long-standing hormone therapy warnings highlights how politics, public trust, and evolving data collide and why “follow the science” is far more complicated—and more vital—than the slogan suggests.
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.
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