FDA removes menopause hormone therapy black box warnings

A hardcover book titled hormone therapy on a table alongside plastic models of chemical structures and a stethoscope.

For more than two decades, warnings about health risks from taking hormone therapy have shaped women’s choices, causing a drastic drop in the number using it to manage disruptive menopause symptoms such as hot flashes and night sweats. But that trend may shift with the impending removal of “black box” warnings on hormone therapy after experts entreated the agency to allow hormone therapy guidance to reflect today’s science.

Although menopause hormone therapy is often called hormone replacement therapy, hormone therapy is now the preferred term, since it replaces only a tiny fraction of the hormones women’s ovaries produce before menopause. Hormone therapy involves taking either estrogen alone or a combination of estrogen and progesterone. It’s available in various formulations including pills, patches, topical gels or creams, and low-dose vaginal estrogen.

Some panelists told the FDA in July 2025 they felt the risks of using hormone therapy were overstated. On Nov. 10, 2025, the agency agreed, announcing it would remove black box warnings from all hormone therapy products containing estrogen. The changes are expected within six months, and labels will be rewritten with age-specific guidance that indicates women may reap long-term health benefits if hormone therapy is initiated within 10 years of the onset of menopause.

Dr. Kathryn Corelli, an internist and menopause specialist at Harvard-affiliated Brigham and Women’s Hospital, believes the FDA review was timely because women are learning more about hormone therapy from social media, books, and articles — and some of the information may refute prior FDA guidance.

“I think the review will make people consider hormones in general, and whether the FDA has updated its guidance appropriately based on the evidence,” Dr. Corelli says.

Why hormone therapy has long been controversial

Hormone therapy use was highly common among women until 2002, when alarming results from the Women’s Health Initiative (WHI) — a landmark research project launched in 1991 — were released. A set of WHI trials suggested that varying forms of systemic hormone therapy that included estrogen and progesterone could increase the risks of cardiovascular problems, breast cancer, endometrial cancer, and possibly dementia. Shortly after, the FDA implemented a black box warning (its strongest available measure short of removing a drug from the market) on all menopause treatments containing estrogen.

But follow-up analyses of WHI data suggested flaws in the original findings. For one, participants primarily included women who were much older than those who typically begin using hormone therapy, and who had underlying risk factors that could skew results. Hormone therapy at the time was also formulated differently than today; now, estrogen is available in lower doses and can be delivered through the skin, which may lower risks further.

The controversy greatly affected the proportion of women using hormone therapy, however. Its estimated use among postmenopausal women declined from about 27% to about 5% from 1999 to March 2020, according to a 2024 paper in JAMA.

“They frightened many women who were very appropriate for hormone therapy and told them it was dangerous, when in reality the risks were quite low and just need to be discussed on an individualized basis,” Dr. Corelli says.

Points to process about hormone therapy

For many women in their 50s and early 60s, the benefits of using hormone therapy can outweigh potential drawbacks if the treatment is tailored to their overall health risks, says Dr. Kathryn Corelli, an internist and menopause specialist at Brigham and Women’s Hospital. If you’re considering hormone therapy, “it deserves an individualized conversation with your doctor,” she says.

During the visit, Dr. Corelli recommends discussing factors that include

your age
years since menopause
specific menopause symptoms and their severity
personal and family history of breast cancer, blood clots, or heart disease
chronic conditions such as high blood pressure, diabetes, high cholesterol, or obesity
bone health, including personal or family history of osteoporosis, or falls or fractures after you turned 40.

“We would consider if there’s anything that could rule you out from taking systemic hormone therapy,” Dr. Corelli explains. “Have you had a heart attack or a stroke? A blood clot in your legs or lungs, hormone-sensitive cancer, or active liver disease? If you don’t have any of those things, then I think about your breast cancer or cardiovascular risk.”

Beyond that, you should be candid with your doctor about which menopause symptoms you’re experiencing and how disruptive they are—“whether you have symptoms like pain with intercourse, mood swings, sleep disturbances, joint pain,” or others, Dr. Corelli says.

Your doctor can explain various hormone therapy formulations — including pills, patches, creams, and more — as well as what dose is likely to be effective for you. “It really depends on your risks,” she says.

The difference with vaginal estrogen

The FDA panelists specifically pushed to remove or revise the boxed label warning on vaginal estrogen because only minimal amounts of estrogen get absorbed from the vagina into the bloodstream. Therefore, vaginal estrogen does not carry the same risks of stroke, blood clots, or cancer. A new study reinforces that point, suggesting that among older women who have had one stroke, those using vaginal estrogen tablets aren’t more likely to have a second stroke than those who don’t use it. The analysis, which involved nearly 57,000 postmenopausal women, was published online Aug. 21, 2025, by the journal Stroke.

The FDA went even further with its removal of black box warnings for all estrogen-containing products. However, it will not remove the boxed warning for endometrial cancer for hormone therapy products containing only systemic estrogen.