A panel of medical experts has urged the hormone therapy FDA to remove black box warnings on menopause treatments, arguing that current labels are preventing women from accessing life-changing care. The July 17, 2025 FDA Expert Panel on Menopause and Hormone Replacement Therapy, led by Commissioner Martin Makary, focused on reassessing the risks and benefits of hormone therapy based on decades of new research since the original Women’s Health Initiative study.
The panel, consisting of 12 experts from various medical specialties including urology, gynecology, and endocrinology, presented a unified call for regulatory changes. Current black box warnings stem from the 2002 Women’s Health Initiative study, which was halted early due to concerns about breast cancer and cardiovascular risks. However, experts argue these warnings have created widespread misconceptions about hormone therapy safety.
Expert Panel Challenges Outdated Safety Concerns
Dr. Heather Hirsch, a board-certified internist, emphasized the critical distinction between systemic and local estrogen treatments during the panel discussion. “Vaginal or local estrogen is categorically safe for all women, period, because it does not travel systemically,” she explained. The expert noted that local estrogen does not increase risks of heart attacks, breast cancers, or strokes, yet inappropriate black box warnings suggest otherwise.
Commissioner Makary opened the discussion by highlighting compelling cardiovascular benefits, citing data showing 25% to 50% reduction in fatal heart attacks when hormone therapy begins within 10 years of menopause onset. This risk reduction is comparable to or greater than that provided by statin medications, according to the presentation.
Scientific Evolution Demands Updated Guidelines
Dr. Rachel Rubin, a board-certified urologist specializing in sexual medicine, called for modernized messaging around women’s urologic health treatments. “Science evolves and so must our warning labels,” Rubin stated, noting that local vaginal hormones are not only effective for sexual health but can prevent more than 50% of urinary tract infections – a guideline-supported fact that remains largely unknown due to education gaps.
Dr. Barbara Levy, clinical professor of obstetrics and gynecology at George Washington University, criticized the inappropriate application of specific study results to all hormone therapy forms. She argued that conflating results from conjugated equine estrogen studies with all hormone therapy represents “a disaster that we’ve been perpetrating for decades.”
The FDA has opened a public comment docket following the panel meeting, specifically requesting perspectives on risks and benefits concerning breast cancer, cardiovascular disease, genitourinary systems, bone health, and dementia. The agency is particularly interested in how these factors differ based on timing of hormone initiation, duration of use, type of hormones used, and administration routes.
Recent studies demonstrate that timing matters significantly – women beginning hormone therapy within 10 years of menopause onset and continuing until approximately age 60 show substantially different risk profiles than those in the original studies. The panel’s recommendations could potentially transform access to menopause care for millions of American women currently avoiding treatment due to fear of overstated risks.