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.
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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 prompted the FDA to require black box warnings in the first place — and which produced controversial findings that 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.
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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.
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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 can reduce the risk of heart disease by as much as 50 percent, and lower the risk of Alzheimer’s disease by 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 crucial 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 shouldn’t shy away from speaking 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.
