Why Experts Want the FDA to Fix Estrogen’s Black Box Warning

For more than 20 years, a black box warning on estrogen products has scared patients, confused doctors and kept women from getting the care they need. That could finally be changing. Last week, an FDA advisory panel voted to recommend revising the warning labels on hormone therapies used to treat menopause symptoms. The 13-member advisory committee, made up of OB-GYNs, urologists, epidemiologists and researchers, agreed that the current language is outdated and misleading.

Vaginal creams, rings and tablets that contain estrogen are used to treat common menopause symptoms like dryness, painful sex and urinary tract infections. Unlike full-body hormone replacement therapy (HRT), they don’t significantly raise hormone levels in the bloodstream. But right now, they still carry the same warning label that was applied to all estrogen-containing products after a major 2002 study linked systemic hormone therapy to breast cancer and cardiovascular risks.

Why This Matters

“This label scares patients and clinicians every day,” said Rachel Rubin, MD, a urologist and sexual medicine specialist at Georgetown who spoke during the public hearing. “UTIs kill the people you love.” She added that topical estrogen has been shown to prevent more than 50 percent of urinary tract infections, which disproportionately affect older women and lead to roughly 7 million hospital visits every year.

Her research team recently published findings showing that if more Medicare patients used vaginal estrogen, the U.S. could save billions in health care costs. “We’ve known this for decades,” she said, “but the label keeps patients from asking for it and keeps doctors from prescribing it.” Prescriptions can cost as little as $13 a tube, but the fear around the black box warning creates an unnecessary barrier to care.

Systemic HRT Was on the Table, Too

While estrogen took center stage, the discussion didn’t stop there. The panel also weighed in on systemic hormone therapy, oral or transdermal HRT used to treat full-body menopause symptoms like hot flashes and night sweats.

Panelists emphasized that the risks flagged in 2002 no longer reflect the full picture. More recent data shows that hormone therapy, when started early in menopause and given at appropriate doses, is both safe and effective for many women. It can even offer protective benefits against heart disease and bone fractures. “Vaginal or local estrogen is categorically safe for all women, period,” said internist and menopause specialist Heather Hirsch, MD. “There is no increased risk of heart attacks, clots or strokes.”

A Bigger Menopause Convo

Doctors say this is about more than a label. It’s about how we talk about menopause, hormone therapy and women’s health as a whole. The panel’s recommendation is part of a broader push to fix long-standing gaps in menopause education and care. “It’s time to remove it and give people the truth,” said Dr. Rubin. While the FDA is not required to follow the panel’s recommendation, experts say it typically does. If the agency updates the warning language, it could mark a major shift, making it easier for women to access safe, effective relief without outdated fears standing in the way.