FDA revisits menopause hormone replacement therapy warnings By HPN Staff The FDA has convened an expert panel to reexamine hormone replacement therapy (HRT) for menopausal women — a major policy moment for a long-debated area of women’s health with changing clinical perspectives. The panel will explore treatments, education and comprehensive care “beyond symptom management,” according to the FDA’s announcement. It’s also a personal priority for FDA Commissioner Marty Makary, who has argued that HRT offers major health benefits when started early in menopause and that millions of women were wrongly discouraged from using it due to misinterpreted data from a decades-old study. Why it matters HRT, once a common treatment for menopause symptoms, fell out of favor in the early 2000s after a major federal study reported increased risks of breast cancer, stroke and blood clots, tipping the overall risk-benefit balance in a negative direction. But more recent analyses of Women’s Health Initiative data suggest that HRT may reduce the risk of breast cancer and death from breast cancer — and that its benefits are greatest when started near the onset of menopause. For now, the debate remains active: how to balance past evidence with new data, and how to give patients options without downplaying risk. The panel itself won’t change federal policy, but it could influence future regulatory decisions, including revisions to warning labels or expanded guidance for clinicians. The big picture Makary, a surgeon and author of ”Blind Spots: When Medicine Gets It Wrong,” has described the treatment gap as a public health failure, saying the medical system has denied women relief from debilitating menopause symptoms due to “medical dogma.” The FDA panel includes several physicians who advocate for HRT, including some affiliated with Let’s Talk Menopause, an advocacy group that has petitioned the FDA to remove the boxed warning on some HRT products. They argue that localized, low-dose forms of HRT — such as creams and rings — carry minimal risk and are being unnecessarily stigmatized. “Removing the boxed warning will empower women and clinicians to make informed, evidence-based decisions and significantly improve the quality of life for millions of women and their families,” wrote members of the Menopause Advocacy Working Group, several of whom are participating in the FDA’s panel. Other experts remain cautious. Diana Zuckerman, president of the National Center for Health Research, told Politico the current warning is “very balanced” and offers sound advice: prescribe the lowest effective dose for the shortest necessary duration. “That’s good advice for pretty much any pharmaceutical,” she added. More context The WHI study primarily tested high-dose, combination oral therapy in older postmenopausal women — a population already at higher baseline risk. Later reviews have suggested that healthier women who start HRT closer to menopause may experience fewer risks and even some benefits. Still, family history of conditions like breast cancer — a key concern for many — makes individualized treatment and risk management essential.
