The U.S. Food and Drug Administration (FDA) has announced the commencement of efforts to eliminate “black box” warning labels from hormone replacement therapy (HRT) products designed to alleviate menopause symptoms, a decision Commissioner Dr. Marty Makary stated is supported by decades of research highlighting the therapy’s advantages and clinical trials that do not corroborate earlier anxieties linking it to increased breast cancer mortality.
Health and Human Services Secretary (HHS) Robert F. Kennedy Jr. stated at a press conference alongside Makary on Monday that the aforementioned “black box” labels, the most stringent warnings the agency can mandate for prescription drugs, were intended to “frighten women and to silence doctors.”
“It cautioned against diseases and dangers that the data simply did not substantiate. FDA bureaucrats acted out of fear, not rigorous scientific standards. And instead of rectifying the record, the medical community reinforced groupthink,” Kennedy stated. “The repercussions have been devastating.”
Makary added that a 2002 study known as the Women’s Health Initiative — which intensified concerns regarding hormone therapy and breast cancer — was “misrepresented and engendered a fear-driven environment.”
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In a Monday op-ed in The Wall Street Journal, published hours before the official announcement, he wrote that HRT, which “comprises estrogen and progesterone (or estrogen alone for women who have undergone a hysterectomy),” is a “significant advancement for many women.”
“It mitigates the short-term symptoms of menopause, including hot flashes, night sweats, mood fluctuations, and weight gain, and when initiated within 10 years of menopause, it provides underappreciated long-term health benefits that even medical professionals may not be fully aware of.”
The “black box” warnings, initially implemented in 2003, were predicated on misinterpreted data and deterred millions of women from utilizing HRT, according to the FDA commissioner.
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Makary emphasized a 1991 UC San Diego review that indicated HRT may decrease fatal coronary events by approximately 50%, and a 1996 study from the University of Southern California that revealed women using estrogen replacement therapy had a 35% reduced risk of Alzheimer’s disease compared to those who did not use it.
Kelly Casperson, a board-certified urologist, remarked at the HHS event that the FDA’s action to remove the “black box” warning label would contribute to “correcting decades of misleading guidance.”
“The FDA’s decision to remove the box warning is not merely regulatory,” she stated. “It’s transformative.”
