For more than 20 years, menopausal hormone therapy has included a warning from the Food and Drug Administration (FDA) outlining the risk of serious adverse effects associated with the drug, including cancer, cardiovascular disease, and possibly dementia.
On November 10, 2025, the FDA announced that drug manufacturers were required to remove these prominent safety warnings.
The Conversation US asked Genevieve Hofmann, a women’s health nurse practitioner at the University of Colorado Anschutz Medical Campus, to explain how this decision will affect health care for people going through menopause or postmenopause.
How was the FDA’s decision made?
When people think about menopausal hormone therapy, they usually think of systemic estrogen and progestins, such as pills or patches that deliver hormones throughout the body.
Health care providers prescribed hormone therapy to manage menopause symptoms, such as hot flashes, night sweats, and mental fatigue, much more widely in the 1980s and 1990s than today. That’s because in the early 2000s, researchers analyzed data from a study called the Women’s Health Initiative and reported that hormone therapy increased the risk of breast cancer, heart disease, blood clots and stroke, as well as cognitive decline after menopause.
After this research was first published in 2002, the use of hormone therapy decreased by 46% in six months, both because clinicians were reluctant to prescribe it and because patients were afraid to take it. In 2003, the FDA added black box warnings—the most serious warnings, indicating risk of serious harm or death—to all menopausal hormone products containing estrogen.
But the researchers soon pointed out methodological flaws in the analysis. And over the past two decades, careful reanalyses of data from that study, as well as more recent studies, have shown that systemic hormone therapy is very safe for most women, although there are nuances in its use.
Meanwhile, women’s health experts have increasingly spoken out over the past five years calling for black box warnings to be removed from a form of menopausal hormone therapy that is applied locally, not systemically. Localized topical estrogen is applied directly to the vagina and surrounding areas, usually in the form of a cream or vaginal insert. It is used to treat the genitourinary syndrome of menopause, which manifests itself with genital and urinary symptoms.
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Although topical estrogen products are extremely safe and were not evaluated in the Women’s Health Initiative study, they also came with FDA warnings.
In July 2025, the FDA convened a panel of experts to discuss what is currently known about the risks and benefits of menopausal hormone therapy. At the meeting, most experts urged the agency to remove warning labels on topical vaginal estrogen products.
The Nov. 10 announcement was the result of that discussion and included both systemic and topical hormone therapy.
Why is systemic estrogen no longer considered unsafe?
Researchers now find that the balance of risks and benefits of systemic hormone therapy for menopause appears to depend largely on when someone starts using hormones, as well as the type, dose, and duration of their use.
For women under age 60 or within 10 years of their last menstrual period, the therapy is much safer than for older women. A 2017 follow-up of participants in the Women’s Health Initiative showed that overall deaths from any cause actually decreased in this younger group of menopausal women taking hormones.
For women who are more than 10 years past their last menstrual period, starting hormone therapy may increase their risk of cardiovascular disease. Researchers now refer to this as the hypothesis of the moment. New studies also support this idea.
Additionally, some ways of delivering hormones to the body were found to be safer than others. Taking estrogen by mouth, as pills or tablets, carries an increased risk of blood clots. Those risks disappear when delivered through the skin using a patch, gel or spray. There are many more options for hormone therapy today than there were in the early 2000s.
Additionally, it is well established that hormone therapy improves bone health by preventing bone loss. Some studies suggest that in younger menopausal women, it may even protect against cardiovascular disease, although this link is still unproven and needs more study.
Unfortunately, many people missed the window of time. In my practice, I see patients who went through menopause 10 or 15 years ago and either did not receive hormone therapy at that time or stopped taking it when the first results from the Women’s Health Initiative were published. Now, they hear about the benefits and many want to try it. But its increased cardiovascular risk may overshadow the benefit.
What about topical estrogen?
Genitourinary syndrome of menopause is ubiquitous: it affects everyone with ovaries going through menopause, and symptoms tend to worsen with age.
They include vaginal dryness, pain during sexual intercourse, and urinary problems, such as increased urgency or frequency, along with incontinence. Urinary tract infections tend to be more common with menopause, particularly in older women. Treating them may require several courses of antibiotics.
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Tissues in the genitourinary area are full of estrogen receptors, which are proteins on cells that bind to the hormone. So adding some estrogen to these areas can help restore the quality and thickness of these tissues, and possibly even promote the growth of healthy bacteria around the vagina and urinary tract. Treatment can greatly improve quality of life and promote better health and longevity.
Despite the safety and effectiveness of topical estrogen, the FDA did not distinguish between it and systemic estrogen when it added black box warnings in 2003. For this reason, many providers whose patients have symptoms related to genitourinary syndrome of menopause have been reluctant to prescribe it. Often, providers simply don’t know that it has a different safety profile than systemic estrogen.
How will removing black box warnings affect patients?
Overall, I see this as a huge win for women and their ability to manage menopausal symptoms. I believe this will make clinicians and patients much less anxious about prescribing and taking this medication.
Clinicians like me, who specialize in women’s health and menopause, and who have followed the research, have been safely prescribing hormone therapy all along. But many general practitioners, who often lacked specific training on menopause or the time and resources to stay abreast of the latest findings, have been more reluctant to do so.
The safety concerns that led to the black box warnings, especially regarding local vaginal estrogen, turned out to be overblown. While clinicians must still consider who is a good candidate for systemic hormone use, evidence shows that for most people, it is a safe option.
Even more importantly, patients who were previously convinced that hormone therapy was unsafe may feel more comfortable discussing it with their provider and considering it. And if they receive a prescription for hormone therapy, I hope that the likelihood of them starting this effective treatment will no longer be hampered by reading an alarming package insert based on outdated evidence.
While this medication is not a magic bullet that reverses aging, starting hormones at the right time can safely improve symptoms that decrease a person’s quality of life. So, if you have bothersome symptoms, consider asking your provider about menopause hormone therapy to manage them.
About the author:
Genevieve Hofmann Associate Professor of Nursing and Women’s Health, University of Colorado Anschutz Medical Campus.
This text was originally published on The Conversation.
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