FDA Removes MHT Black Box Warning: What You Need to Know
Dec 3 2025 ・ 9 min read
The FDA's November 2025 decision to remove the black box warning from most hormone therapy products marks a turning point for women going through menopause. Our expert, Jen Wagner, breaks down how this affects your care.
In a landmark decision announced in November 2025, the U.S. Food and Drug Administration (FDA) approved the removal of the broad “black box” warning from many menopausal hormone therapy (MHT) products. This change reflects a major reinterpretation of risk versus benefit — and may open the door for more women to consider MHT for symptom relief and long-term health.
Why the FDA Removed the Black Box Warning
The boxed warning stems from data published in the early 2000s, most notably the Women’s Health Initiative (WHI) study. The WHI suggested an increased risk of serious events — including cardiovascular disease, stroke, blood clots, breast cancer, and potentially dementia — in women taking certain kinds of hormone therapy. These findings led the FDA to require the strongest safety label — the black box — on MHT products containing estrogen and/or progestogen.
The warning had a significant impact: Many clinicians became reluctant to prescribe MHT, and many patients likewise steered away, even when they were good candidates.
Why Is the Warning Being Removed Now?
Several key developments prompted the FDA’s reversal:
Newer Evidence, Different Risk Profile
Re-analysis of the WHI has shown that the most severe risks were overgeneralized (the increase in breast cancer risk is similar to the increased risk associated with advancing age or obesity). In particular, women who begin MHT within 10 years of menopause onset or before age 60 appear to face much lower risks than previously described.
Some of the earlier studies used hormone formulations that are no longer common and involved older women (the average age was around 63 in the WHI).
The FDA conducted a comprehensive review and convened an expert panel to reassess the balance of harms and benefits.
Labeling Modernization and Nuanced Risk Communication
Rather than a single, one-size-fits-all warning, the FDA now wants labels to reflect more nuanced, product-specific risk data.
The agency is also dropping a blanket recommendation that MHT be used at the lowest effective dose for the shortest duration. Instead, they’re encouraging personalized treatment decisions made between patients and their doctors.
However, not all boxed warnings are being removed. The FDA will maintain a black box for the risk of endometrial cancer with systemic estrogen-only therapy in women with a uterus, where unopposed estrogen increases that risk.
What Does This Mean for the Future of MHT?
The removal of the black box warning could have a wide range of implications:
Improved Access and Reduced Stigma
The fear associated with the black box may have deterred many women from considering MHT. Its removal could help normalize MHT as a viable, evidence-based treatment for menopausal symptoms.
More Personalized Care
By shifting to more personalized risk assessment and allowing for doctors’ advice, therapy can be better matched to individual patients — in timing (relative to menopause), formulation (pill, patch, vaginal, etc.), and duration.
Reevaluation of Benefits
Emerging data suggest that starting MHT earlier (within 10 years of menopause) may offer more than symptom relief — possibly reducing risks of heart disease, fractures, and cognitive decline.
Ongoing Caution
Despite the removal, risks remain. The updated labels will still include relevant safety information, and MHT may remain unsuitable for certain demographics (e.g., women with a history of hormone-sensitive cancers).
The Bottom Line
The FDA's move to remove the black box warning from many MHT products marks a major shift — from fear-based messaging rooted in older data to a more nuanced, evidence-driven approach. For many women, especially those early in menopause, this opens the door to safer, more effective treatment options. As with any medical therapy, decisions should be made individually, in consultation with a knowledgeable healthcare provider.
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FACT SHEET: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products
Women’s Health Initiative
About the Expert
About the Expert
Jennifer Wagner
MD, Chief Health and Performance Officer
Dr. Jennifer Wagner is a board-certified anesthesiologist with deep medical expertise and a lifelong commitment to performance and well-being. She played Division 1 soccer and earned a degree in Biological Sciences at Clemson University, followed by a master’s in Exercise Physiology and an MD from the University of Arizona. After her residency and fellowship in pediatric anesthesia at Stanford University, she remained on faculty for eight years, serving in clinical and leadership positions.
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