By_Suraj Karowa/ ANW
November 13, 2025
In a bold reversal hailed by some as a correction of “one of the greatest screw-ups of modern medicine,” the U.S. Food and Drug Administration announced Monday the removal of a longstanding black box warning on hormone replacement therapy (HRT) for menopause symptoms.
The decision, spearheaded by FDA Commissioner Dr. Marty Makary and U.S. Health and Human Services Secretary Robert F. Kennedy Jr., aims to restore access to treatments that officials say could slash risks of heart disease, dementia, and even add years to women’s lives.
Speaking at a press event in Washington, D.C., Makary described the 2003 warning—added after a landmark study raised alarms about cardiovascular and cancer risks—as a product of “medical groupthink” fueled by misrepresented data.
“This therapy ranks near antibiotics and vaccines in its impact,” he declared, crediting HRT with alleviating debilitating symptoms like hot flashes, night sweats, and mood swings that have derailed marriages and careers.
Kennedy, flanked by his wife and daughters, echoed the sentiment, touting estrogen-based pills, patches, creams, and injections as potential lifesavers that could extend life expectancy by a decade.
The announcement marks a dramatic pivot from two decades of caution. In 2002, the Women’s Health Initiative (WHI), a massive government-funded trial, was halted early when an independent safety board found that combined estrogen-progesterone therapy increased risks of breast cancer, heart disease, stroke, and blood clots in postmenopausal women.
The fallout was swift: HRT prescriptions plummeted by 80%, leaving millions wary of what was once a staple for managing menopause, which affects over 1 million U.S. women annually starting around age 51.
Makary blamed the “scary” label for stifling innovation and perpetuating stigma around women’s health.
“It spread fear and dismissal of real suffering,” he said. The FDA’s move retains a narrower caution: Women with a uterus must pair estrogen with progesterone to avoid endometrial cancer risks.
Officials cited a recent expert panel and an internal evidence review as justification, promising a forthcoming publication. Yet, the linchpin—a JAMA Viewpoint co-authored by Makary—has drawn fire as a selective opinion piece rather than a rigorous meta-analysis.
Physicians and researchers applaud the destigmatization but urge restraint, warning that the fanfare risks overselling HRT as a panacea.
“It’s not a miracle drug,” said Dr. Leslie Cho, director of the Cleveland Clinic’s Women’s Cardiovascular Center and lead author of a 2023 comprehensive review. “Benefits vary by age, health history, and delivery method. We’re seeing cherry-picked data that ignores real risks.”
Critics point to Makary’s citation of a 2023 study from The Cancer Journal (not the prestigious Cancer journal) claiming a 30-50% drop in coronary heart disease from HRT.
The paper itself notes that randomized trials show “null effects” overall, particularly for women over 45. An HHS fact sheet referenced decades-old reviews for a 50% heart disease reduction claim, sidelining newer data. A 65% dementia risk cut? That’s from a 2005 Danish study of just 343 women.
The process itself has sparked procedural concerns. Unlike removals for drugs like diabetes med Avandia (2013) or Chantix (2016), no advisory committee convened.
Makary dismissed such panels as “bureaucratic and conflicted.” Major groups like the American College of Obstetricians and Gynecologists (ACOG), Menopause Society, and Endocrine Society say they weren’t consulted—a departure from standard protocol.
For vaginal estrogens—low-dose creams treating dryness and urinary issues that stay localized—the change is broadly welcomed. “The warning was never evidence-based for these,” said Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital.
They’ve been unfairly lumped with systemic options like pills, which flood the bloodstream and may quintuple clot risks.
Transdermal patches, gels, and sprays fare better in recent studies, bypassing liver metabolism that amplifies oral estrogen’s dangers.
But experts like Dr. Cynthia Stuenkel of UC San Diego argues the blanket removal ignores this nuance. “Oral forms still warrant warnings based on WHI data,” she said.
Evidence on long-term perks remains mixed. HRT shines for symptom relief and osteoporosis prevention: Framingham Heart Study data shows current users cut hip fracture risk by 65%, with each year of use reducing odds by 6%.
Yet, for heart disease or dementia prevention in healthy women starting post-60? Trials like WHI show no broad benefits—and potential harms.
“We need balance, not hype,” said Dr. Rebecca Thurston, assistant dean of women’s health research at the University of Pittsburgh. Her recent JAMA Internal Medicine piece frames HRT as “neither panacea nor poison.”
Contraindications abound: Avoid those with uncontrolled hypertension, high cholesterol, or clotting history. New nonhormonal options like Veozah and Lynkuet offer hot flash relief without estrogen.
Patient anecdotes underscore the stakes. Dr. Stephanie Faubion of the Mayo Clinic recounts postmenopausal women seeking HRT for tinnitus or anti-aging—misconceptions the announcement might fuel. ACOG’s Dr. Steven Fleischman supports more doctor-patient talks but stresses individualized risks: “Systemic therapies aren’t risk-free.”
As the dust settles, the FDA insists it’s empowering choices, not dictating them. “Talk to your doctor,” Makary reiterated. Kennedy’s personal stake—addressing his family—adds emotional weight, but experts like Dr. Marcia Stefanick, a WHI investigator, sees echoes of past swings: From estrogen in the water to black-box terror, now to unbridled enthusiasm.
For the 61 million U.S. women in menopause or perimenopause, the message is clear: Options abound, but so do trade-offs. Amid affordability crises and anti-aging trends, this pivot could reshape women’s health—or reignite old debates if risks resurface. As Thurston puts it, “Women deserve a range of choices, not extremes.”