For more than two decades, hormone therapy used during menopause carried an FDA “black box” warning. The label warned patients of possible serious risks, including breast cancer, cardiovascular disease, blood clots and dementia.
On Nov. 10, 2025, the FDA announced that drug manufacturers should remove this warning from both systemic and topical hormone products.
The Conversation U.S. asked Genevieve Hofmann, a women’s health nurse practitioner at the University of Colorado Anschutz Medical Campus, to explain what this change means for people experiencing menopause and postmenopause.
How the FDA Reached Its Decision
Most people think of hormone therapy as systemic treatment—estrogen pills, patches or other products that send hormones throughout the body. In the 1980s and 1990s, these therapies were widely prescribed to treat hot flashes, night sweats and cognitive symptoms.
That changed in 2002, when early findings from the Women’s Health Initiative suggested higher risks of breast cancer, heart disease, blood clots, stroke and cognitive decline. Hormone therapy use quickly dropped by almost half. In 2003, the FDA added black box warnings to all estrogen-containing products.
However, over the following two decades, researchers identified flaws in the original analysis. New studies and updated reviews showed that hormone therapy is safe for most women, with important nuance depending on age, timing, and the form of treatment.
Experts also pushed the FDA to reconsider warnings placed on topical estrogen, such as vaginal creams and inserts. These products treat the genitourinary syndrome of menopause and act only in the local tissues. They were never included in the Women’s Health Initiative research, yet received the same warning.
In July 2025, an FDA advisory panel reviewed the latest evidence. Most experts recommended removing the warning from topical products and re-evaluating systemic therapy as well. The FDA’s November announcement reflects that consensus.
Why Systemic Estrogen Is No Longer Seen as Universally Risky
New evidence shows that the risks and benefits of systemic hormone therapy depend heavily on timing. Women under 60—or within 10 years of their last menstrual period—experience significantly lower risks. A 2017 follow-up of Women’s Health Initiative participants even showed a reduction in overall deaths in this younger group.
For women who begin therapy more than 10 years after menopause, the risk of cardiovascular disease may rise. Researchers now call this the “timing hypothesis,” and newer studies support this model.
The method of delivery matters too. Estrogen pills increase the risk of blood clots, but that risk largely disappears when estrogen is absorbed through the skin by patch, gel or spray. Many more delivery options exist today than in 2002.
Hormone therapy is also known to protect bone health by slowing bone loss. Some studies suggest it may help prevent cardiovascular disease in younger menopausal women, though more research is needed.
Many people who missed the ideal timing window—often because they were advised to stop hormones after the original study—now want to restart treatment. For them, the risks may outweigh the benefits.
The Importance of Topical Estrogen
Genitourinary syndrome of menopause is extremely common. Symptoms include vaginal dryness, pain during sex and urinary changes such as urgency, frequency and incontinence. Urinary tract infections also become more frequent with age.
Estrogen receptors are abundant in genital and urinary tissues. Adding estrogen locally can rebuild tissue thickness, improve comfort, and may support healthy bacteria in the vagina and urinary tract. This can significantly improve quality of life.
Despite strong evidence of safety, topical products carried the same black box warning as systemic hormones for more than 20 years. Many clinicians avoided prescribing them simply because they assumed the risk profiles were the same.
What Removing the Warning Means for Patients
Experts expect the FDA’s decision to reduce fear around hormone therapy. Clinicians who were reluctant to prescribe these medications may now feel more confident offering them. Specialists who already follow the research have been prescribing hormone therapy safely, but many general practitioners have lacked up-to-date training.
The outdated warning labels discouraged many patients from considering hormone therapy at all. Without the alarming black box warning, more people may feel comfortable discussing treatment options and receiving therapies that could ease their symptoms and improve long-term health.
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