FDA Removes Strictest Black Box Warning From Menopause Hormone Therapy
The warning, based on a conclusion by researchers in 2002, stopped many women from taking effective drugs for symptoms like hot flashes and night sweats, the FDA said.
The U.S. Food and Drug Administration (FDA) is removing the black box safety warning from hormone therapies containing estrogen that are used to treat menopause symptoms like hot flashes and night sweats.
Hormone replacement therapy (HRT) will no longer carry a black box warning about an increased risk of breast cancer, heart disease, and dementia, the FDA said.
Instead, revised product labels for hormone therapy treatments will encourage women to discuss the risks and benefits with their doctors, and to start hormone therapy within 10 years of menopause or before age 60, the FDA said.
The change is “quite a surprise,” says JoAnn Manson, MD, DrPH, a professor at Harvard Medical School and the chief of preventive medicine at Brigham and Women’s Hospital in Boston.
Dr. Manson worked on the landmark Women’s Health Initiative (WHI) study that, decades ago, prompted the FDA to require black box warnings. Findings of that research led many patients and physicians to shy away from HRT.
“The alarming black box warning in general has led to underutilization of HRT among many women who are appropriate candidates and would benefit from treatment,” Manson says. “Removing it will be a step in the right direction if women are still provided with the safety information on the label so they can still read the details of the study.”
What Hormone Therapy Does — and Why It Got a Black Box Warning
Most women go through the menopausal transition (perimenopause) between their mid-forties and mid-fifties, as declining levels of the hormones estrogen and progesterone lead to the end of monthly menstrual cycles. Often, this process is accompanied by a wide range of symptoms, including hot flashes and night sweats as well as mood swings, joint pain, vaginal dryness, insomnia, and memory problems.
Hormone therapy can ease many of these issues.
But in 2002, the researchers behind the WHI study concluded that the possible harms of hormone pills for postmenopausal women — an increased risk of breast cancer, heart disease, stroke, and blood clots — outweighed the potential benefits, including strengthening bones to prevent fractures.
This led the FDA to put black box warnings on all forms of menopausal hormone replacement therapy.
Before the Women’s Health Initiative study, about 1 in 4 women took some form of hormone therapy, says Stephanie Faubion, MD, the medical director of the Menopause Society and the director of Mayo Clinic's Center for Women’s Health in Rochester, Minnesota.
But after the WHI study, hormone therapy use dropped dramatically — today, only about 1.7 percent of U.S. women use it, Dr. Faubion says.
What Current Research Says About HRT
The authors of the WHI study didn’t take into account that participants were 63 years old on average — much older than many women who start going through menopause, according to the FDA.
More recent studies have found that women who start hormone therapy within 10 years of the onset of menopause (generally before age 60) don’t have the elevated risk of breast cancer or heart issues seen in the WHI.
Newer research suggests that HRT used by these younger women can reduce the risk of heart disease by as much as 50 percent, and lower the risk of Alzheimer’s disease by up to 35 percent, according to the FDA.
Vaginal vs. Oral Hormone Replacement Therapy
Doctors have been advocating for years for the FDA to remove the boxed warning from vaginal estrogen because this form of hormone replacement therapy doesn’t have the same safety issues as systemic hormone pills.
Vaginal estrogen can be especially effective for easing urinary symptoms and issues like vaginal dryness or painful intercourse that can accompany menopause.
Crucially, vaginal hormones don’t release a lot of estrogen throughout the entire body, minimizing risks seen with systemic forms of estrogen that come in pill form, says JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia in Charlottesville.
“Removing the scary boxed warning from local vaginal estrogen is a victory for women's health and for those who care for and about menopausal women,” Dr. Pinkerton says.
“We wholeheartedly support and applaud the FDA's monumental decision to remove the boxed warning for local vaginal estrogen used to treat menopause-related vaginal and urinary symptoms.”
Doctors are more measured, however, in their enthusiasm for the FDA’s removal of the boxed warning for HRT pills. It remains critical for patients to discuss the pros and cons of oral hormones with their doctor to make an informed decision about whether this option makes sense for them, Pinkerton says.
“In general, the benefits are greater and the risks lower for younger women initiating hormone therapy for symptom management, closer to the menopause transition,” Faubion says. “The removal of the box warning does not change any of this.”
HRT Is Not a One-Size-Fits-All Treatment
Ultimately, the removal of the boxed warning from hormone therapy may be a good thing if it gets more women to talk with their doctors about their menopause symptoms and treatment options, Manson says.
Hormone therapy is still not suitable for some women, including those with a history of estrogen-sensitive breast cancer, Manson pointed out in an earlier interview with Everyday Health — another reason why women need to speak with their doctors.
“Instead of being scared away by a one-size-fits-all black box warning, they can have a more nuanced conversation and make an informed decision based on their individual circumstances,” Manson says.
What Do Women Need to Know About Menopausal Hormone Therapy?
Dr. Kelly Casperson, MD, breaks down what women need to know about estrogen, progesterone, and testosterone.
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EDITORIAL SOURCES
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Resources
FACT SHEET: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products. U.S. Food and Drug Administration. November 10, 2025.
Rossouw J et al. Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women’s Health Initiative Randomized Controlled Trial. JAMA. July 17, 2022.
HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. U.S. Food and Drug Administration. November 10, 2025.
Emily Kay Votruba has copy edited and fact-checked for national magazines, websites, and books since 1997, including Self, GQ, Gourmet, Golf Magazine,Outside, Cornell University Press, Penguin Random House, and Harper's Magazine. Her projects have included cookbooks (Padma Lakshmi's Tangy Tart Hot & Sweet), self-help and advice titles (Mika Brzezinski's Know Your Value: Women, Money, and Getting What You're Worth), memoirs (Larry King's My Remarkable Journey), and science (Now You See It: How the Brain Science of Attention Will Transform How We Live, Work, and Learn, by Cathy Davidson). She started freelancing for Everyday Health in 2016.
Lisa Rapaport is a journalist with more than 20 years of experience on the health beat as a writer and editor. She holds a master’s degree from the UC Berkeley Graduate School of Journalism and spent a year as a Knight-Wallace journalism fellow at the University of Michigan. Her work has appeared in dozens of local and national media outlets, including Reuters, Bloomberg, WNYC, The Washington Post,Los Angeles Times, Scientific American, San Jose Mercury News, Oakland Tribune, Huffington Post, Yahoo! News, The Sacramento Bee, and The Buffalo News.
