Removing the most dire warning from hormonal therapies to treat menopause is likely the right call, women’s health experts say, but exuberance for the treatments could be getting ahead of the evidence.

Since 2003, the U.S. Food and Drug Administration required a “black box” warning — reserved for the most-serious side effects — on products that use estrogen, progesterone or both to treat symptoms such as hot flashes and vaginal dryness. The black box warned of an increased risk of blood clots and certain heart problems.

On Monday, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. announced providers would no longer see the black box, and described the decision to place the warning as a betrayal of women that denied them “strength, peace and dignity,” and may have shortened their lives.

Other top officials said in a news release that estrogen would help women prevent chronic diseases while “extending their vigor,” and that female brains need estrogen to function at their best.

“With the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy,” FDA Commissioner Dr. Marty Makary wrote in an opinion piece in the Journal of the American Medical Association.

Removing the black box is the right call for forms of hormone therapy delivered directly to the vagina, and may be for pills and other “systemic” medications, though those require a nuanced conversation about risk, said Dr. Jill Liss, an associate clinical professor of obstetrics and gynecology at University of Colorado’s Anschutz Medical Campus.

But despite what Kennedy and other federal officials said, no studies have proven that hormone therapy prevents heart disease or dementia, said Liss, who is on the board of the Menopause Society. It is, however, a highly effective and generally safe option for treating hot flashes and vaginal symptoms of perimenopause, and delays bone loss that can lead to osteoporosis, she said. Some women also report better sleep and mood.

“It’s a really nice tool for the menopause transition,” she said. Some of the comments from federal officials “gave this notion that hormone therapy is more miraculous than it really is.”

Older women who didn’t get hormone therapy while the black box was in place likely suffered more symptoms than they would have if it had remained widely available, but they don’t need to worry that their long-term health took a hit, Liss said.

Black box warnings don’t technically limit availability, but doctors are more reluctant to prescribe medications that carry one, and women who saw media coverage of hormone therapy’s risks were less likely to seek it out, she said.

“It’s not an anti-aging medication,” Liss said.

Views on hormone therapy have shifted dramatically over the years. In the 1960s, doctors recommended it for almost all women in menopause, often with an eye toward pleasing their husbands. Concerns about a kind of uterine cancer dampened enthusiasm in the 1970s, though interest started to pick up again as data showed combining two hormones largely eliminated that risk.

While the research clearly showed that hormone therapy was effective for treating some of the more bothersome symptoms of menopause, no one knew whether it had any effect on women’s risk of chronic diseases.

In the 1990s, the Women’s Health Initiative study tried to answer that question. The trial stopped early, in 2002, after finding an increase in breast cancer diagnoses and blood clots among women taking one type of hormone therapy.

For the first decade or so of the millennium, most gynecologists took the view that women should avoid hormonal therapy, said Dr. Katie Rustici, one of the gynecologists certified in menopause care at Intermountain Health, which has a clinic for holistic menopause care in Denver.

As of 2020, about 5% of women who reported they were in the menopause transition were taking estrogen, progesterone or a combination product, down from more than one-quarter in 1999.

Later analyses found that women who started hormone therapy in their 40s and 50s had small increases in risk, with about six additional breast cancer cases and five cases of heart disease or stroke for every 10,000 people treated. They had a lower risk of broken bones, diabetes and dying during the follow-up period.

The risks are higher for women who start hormone therapy after 60. The study didn’t last long enough to generate conclusions about the safety of starting early and continuing to take hormones well past when perimenopause symptoms typically end, though the risk is clearly lower than starting late, Liss said.

Rustici said she typically sits down with patients to reevaluate hormone use after about five years. The risk of breast cancer continues to rise with longer use, but some women are willing to accept that trade-off because they report more energy and better sexual functioning, she said.

“There really is a piece here that is patient autonomy,” she said.

Even so, systemic hormone therapy isn’t an option for breast cancer survivors or women who’ve had heart attacks, strokes or certain high-risk blood clots, Rustici said. Those patients generally can use estrogen products applied in the vagina, however, because only trace amounts of hormones reach the rest of the body.

Vaginal estrogen won’t help with hot flashes and night sweats, but patients can get some relief from using antidepressants or the anti-seizure drug gabapentin, Rustici said. A new class of drugs works on the brain’s temperature control mechanisms, though those aren’t an option for women with liver problems.

Ultimately, each woman’s symptoms, risks and priorities — all of which shift over time — need to guide conversations with her doctor about treatments during menopause, Liss said.

“What’s right for your friend or your mother or your sister could be different from what’s going to be right for you,” she said.

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