FDA removes warning for hormone replacement therapy for menopause

Ariel Cohen, CQ-Roll Call on Nov 10, 2025

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WASHINGTON — The Food and Drug Administration said Monday that it will reverse two decades of precedent by removing “black box” warnings on hormone replacement therapy products for menopause, with the intent of increasing access to products to relieve common symptoms.

The warnings of negative long-term health effects from such therapy will be removed, but not warnings of endometrial cancer for systemic estrogen-alone products. At an announcement at the Department of Health and Human Services headquarters in Washington, D.C., officials touted long-term health benefits of taking the treatment within 10 years of the onset of menopause.

The warning stemmed from a government-run clinical trial in 2003 that concluded hormone replacement therapy for menopause increased the risk of heart disease and breast cancer. Since then, doctors have cautioned patients to use the treatment sparingly. The FDA black box warning is the strictest one the agency issues.

Trump administration health officials said the 2003 data has long been misinterpreted and the therapy could actually improve health outcomes. Menopausal women produce less estrogen and progesterone that hormone therapy treatment can restore, while relieving symptoms like bone loss, hot flashes and night sweats.

“Hormone replacement therapy may improve the health outcomes of women at a population level more than any other intervention arguably with the exception of, say, antibiotics or vaccines,” FDA Commissioner Marty Makary said on Monday.

The FDA convened an expert panel over the summer to discuss removing the warnings from low-dose vaginal estrogen. The agency received thousands of comments.

Officials cited research that demonstrates estrogen therapy is generally safe for healthy, newly menopausal women, but the risk profile varies depending on whether the therapy is taken vaginally or via pills, pitches, gels or sprays.

Makary and other experts warned that it is important for doctors and patients to have nuanced conversations about starting the therapy.

The American College of Obstetrics and Gynecologists applauded the administration for making the estrogen products available to more women, saying the modification of the warning labels was “years in the making.” The women’s health organization has long advocated for the use of low-dose vaginal estrogen for people who suffer from vaginal and urinary symptoms of menopause.

But the group warned against the use of compounded estrogen products, which are not approved by the FDA, and said physicians and patients need to understand the distinctions between various products.

“It is important to distinguish that systemic estrogen products — such as oral estrogen and transdermal patches, gels, and sprays — have a different safety profile than low-dose vaginal estrogen. Like all medications, systemic estrogen products are not without risk,” the group’s president, Steven Fleishman, said in a statement.

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