On November 10, 2025 the FDA announced a change to the labeling for menopausal hormone therapy (MHT). This was big news, and it has major ramifications for our patients.
What Are the Changes to the Black Box Labels for MHT?
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They’re removing the black box warnings on all MHT products that warn against the risks of cardiovascular disease, breast cancer, and probable dementia.
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They’re adding language to the medication’s package insert recommending that hormone therapy be started in women younger than 60 or within 10 yrs of starting menopause.
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They’re removing the recommendation to use MHT at the lowest dose for the shortest amount of time.
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They’re removing any warnings about probable dementia.
What Didn’t Change?
What Do The Experts Say?
The medical community has been clamoring for the removal of the black box warning on topical estrogen for a long time, and most people are thrilled about that step. However, some experts are concerned that by removing all the cautionary language for systemic products, women won’t be as aware of the risks posed by MHT to certain populations, including those with cardiovascular disease or hormone-positive breast cancer.
ACOG President Dr. Steven Fleischman said, in his response to the FDA’s announcement, “It is important to distinguish that systemic estrogen products—such as oral estrogen and transdermal patches, gels, and sprays—have a different safety profile than low-dose vaginal estrogen. Like all medications, systemic estrogen products are not without risk, and their use should be based on an individualized conversation between patients and their clinician.”
Discussions of MHT are nuanced. For more on the basics of MHT, check out our free audio course, This is Menopause, and to stay up to date on the latest developments, subscribe to Primary Care Reviews and Perspectives.
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