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The U.S. Food and Drug Administration (FDA) has announced that it will begin removing “black box” warning labels for hormone replacement therapy (HRT) products from hormone replacement therapy (HRT) products. Symptoms of menopauseCommissioner Dr. Marty McCurry said the move is supported by decades of research and clinical trials on the benefits of the therapies, which did not confirm previous concerns that these therapies were associated with increased breast cancer mortality.
Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. He told a news conference Monday with McCulley that so-called “black box” labels, the strongest warnings the agency can require on prescription drugs, are aimed at “scaring women and silencing doctors.”
“They warned of diseases and dangers that the data simply did not support. FDA bureaucrats reacted out of fear rather than the gold standard of science. And instead of correcting the record, the medical establishment reinforced groupthink,” Kennedy said. “The results were devastating.”
On July 29, 2025, at a press conference at HHS Headquarters in Washington, DC, FDA Commissioner Dr. Marty McCulley and Department of Health Secretary Robert F. Kennedy Jr. announced a warning letter to companies selling products containing 7-hydroxymitragynine. (Salk Loeb/AFP via Getty Images)
McCurry added that a 2002 study known as the Women’s Health Initiative fueled concerns that: Hormone therapy and breast cancer — “Misrepresented and created a fear machine.”
He wrote: monday editorial “HRT, which consists of estrogen and progesterone (and only estrogen for women who have had a hysterectomy),” was published in the Wall Street Journal hours before the official announcement that it was “a breakthrough for many women.”
“Although it relieves short-term symptoms of menopause such as hot flashes, night sweats, mood swings, and weight gain, the long-term health benefits of starting less than 10 years after menopause are underestimated and may not be well understood, even by doctors.”
Hormone replacement therapy. It is used to manage the symptoms of menopause by replacing hormones that the body no longer produces in sufficient quantities.
The “black box” warnings, first added in 2003, were based on misinterpreted data and reportedly deterred millions of women from using HRT. FDA Commissioner.
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Professor McCurry highlighted a 1991 University of California, San Diego review that found HRT could reduce fatal coronary events by about 50%, and a 1996 University of Southern California study that found that women using HRT. estrogen replacement therapy Compared to non-users, they had a 35% lower risk of Alzheimer’s disease.
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Urologist Kelly Casperson said at the HHS event that the FDA’s move to remove the “black box” warning label will help “correct decades of misleading guidance.”
“FDA’s decision to remove the box warning is not just a regulatory one,” she said. “It’s revolutionary.”
