FDA to remove Black Box warning from hormone replacement therapy, marking major shift in menopause care
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The shift marks the first significant reassessment of HRT safety in more than two decades and follows a detailed scientific review of the treatment’s risks and benefits. The decision eliminates warnings about cardiovascular disease, breast cancer and possible dementia, while retaining the endometrial cancer warning for estrogen-only treatments, as cited in a report by Pharmacy Times.
The announcement was made by Secretary of Health and Human Services Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, MD, MPH, underscoring the magnitude of change. Both highlighted that outdated science once hindered necessary care for millions of women experiencing menopausal symptoms.
“Today, we stand up for every woman experiencing symptoms of menopause who wants to learn their options and receive potentially life-changing treatment,” Kennedy said. As quoted in a report by Pharmacy Times, “More than two decades of bad science and bureaucratic inertia have left women and doctors with an incomplete view of HRT. We are returning to evidence-based medicine and giving women back control over their health.”
ALSO READ: What does 67 mean, who made the 67 meme and why is it so popular? Makary echoed that sentiment, noting decades of missed opportunities in women’s health. “Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma based on distortion of risk,” Makary said. As quoted in a report by Pharmacy Times, “For too long, women’s health issues have been under-recognized. Women and their doctors must make decisions based on data, not fear.”
Why did the FDA reverse its hormone therapy warning?
HRT has long been used to manage symptoms caused by decreasing estrogen levels, including hot flashes, mood swings and vaginal dryness. But use plummeted in the early 2000s after the Women’s Health Initiative suggested an increased risk of breast cancer, dementia and cardiovascular disease. These findings were later challenged; because many of the study participants were older than the typical age of menopause and were using outdated hormone formulations.
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The FDA’s latest review reflects more recent randomized studies showing that women who started HRT before age 60 or within 10 years of menopause saw significant benefits, including reduced death rates, reduced fracture rates, and reduced risk of cardiovascular disease and Alzheimer’s disease.
How has previous research shaped menopause treatment?
The effects of the original WHI study were far-reaching. As Kennedy noted, “Since that decision, more than 50 million American women have feared treatments that could ease their pain and extend their lives. Before the panic, one in four women was using hormone replacement therapy, and today that rate is less than one in 20.”
Makary emphasized how deeply the results are reflected in daily life. “HRT saved marriages, saved women from depression and prevented children from becoming motherless,” he said. “Let’s be honest, the male-dominated medical profession has minimized menopausal symptoms, and as a result, women’s health problems have not received the attention they deserve. More than 80% of women have severe symptoms that last up to eight years.”
What does this decision mean for women in the future?
The update comes with new approvals aimed at expanding access to care, including the first generic version of Premarin in more than 30 years and a non-hormonal treatment for vasomotor symptoms. FDA reports updated data showing HRT reduces cardiovascular disease by 30%-50%, Alzheimer’s by 35%, and fractures by 50%-60%.
Kelly Casperson, MD, emphasized the impact of outdated fears: “If a patient receives a prescription from their doctor and brings it home, nearly one-third will never use it because of the fear created by the incorrect warning label. Today there is hope. The evidence now outweighs inaction. FDA’s decision to remove the boxed warning is not just regulatory. It is revolutionary.” In a report cited by MHE.
For millions of people experiencing menopause, with symptoms affecting more than 80% of women and often lasting eight years, this decision represents an important step towards restoring choice, confidence and access to medically supported treatment.
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FAQ
Why did the FDA lift the warning?
After reviewing more recent research, the FDA concluded that past risk concerns were exaggerated and based on flawed initial studies.
Are there any warnings left?
Yes, the endometrial cancer warning remains valid for estrogen-only therapy.
