In November 2025 the US Food and Drug Administration (FDA) announced that it would remove the boxed warnings about cardiovascular disease, breast cancer and probable dementia from the labels of menopause hormone therapy (often called HRT). According to the announcement, the boxed warning about endometrial cancer remains on systemic estrogen-only products. The change does not mean hormone therapy is risk-free, and it does not change who should avoid it.
This article explains the announcement in plain language. It is general education, not advice to start, change or stop any medication.
What is a boxed warning, and why did HRT have one?
A boxed warning (sometimes called a "black box" warning) is the most prominent warning on a US drug label. Menopause hormone therapy received one in the early 2000s, after the Women's Health Initiative (WHI) trials reported higher rates of breast cancer, heart disease, stroke and blood clots in women taking certain hormone products (JAMA, 2002). Prescriptions fell sharply in the years that followed.
What exactly did the FDA change in 2025?
Based on the FDA's November 2025 announcement:
- The boxed warnings about cardiovascular disease, breast cancer and probable dementia are to be removed from menopause hormone therapy labels.
- The boxed warning about endometrial cancer stays for systemic estrogen-only products, because estrogen taken without a progestogen can thicken the lining of the uterus.
- Labels are to include information about the timing of therapy, with the announcement pointing to people who start before age 60 or within about 10 years of menopause.
- The other warnings and precautions in the label, including those about blood clots and stroke, remain part of the prescribing information.
Why did the FDA make this change?
The FDA said the original warnings relied heavily on WHI data from women whose average age was in their 60s and who, in many cases, started therapy more than a decade after menopause. Later analyses of the same trials, and other studies, reported that the balance of risks and benefits differs by age, by time since menopause, and by the type and route of hormone used. The agency also cited concern that the warnings had discouraged people from discussing symptom treatment with their doctors.
What does this change not mean?
- It does not mean hormone therapy has no risks. Blood clots, stroke, gallbladder disease and, with longer combined use, a small increase in breast cancer risk are still reported in the research (The Lancet, 2019).
- It does not change who should not use it. People with a history of breast cancer or other hormone-sensitive cancer, blood clots, stroke, heart attack, active liver disease, unexplained vaginal bleeding, or who are pregnant, are still generally not candidates.
- It does not apply to Canada automatically. This was a US labelling decision. Product labels in Canada are reviewed separately and may not change at the same time or in the same way.
- It says nothing in favour of compounded hormones. The announcement concerns regulated products; custom-compounded hormone preparations are not standardized or tested in the same way.
What should you do if you are thinking about hormone therapy?
Talk with your family doctor or another physician. A useful conversation usually covers your symptoms and how much they affect daily life, your age and time since menopause, your personal and family medical history, blood pressure and screening, and non-hormonal options. If you already take hormone therapy, do not stop or change it because of news coverage; raise any questions at your next appointment.
Dr. Charles Jiang, a licensed physician in British Columbia, is RAAC's lead physician. Whether any treatment is appropriate is a decision made with your own physician after a proper assessment.
Frequently Asked Questions
Did the FDA say hormone therapy is safe now?
No. The announcement changes how prominently certain risks are displayed and adds information about timing. The label still lists risks and precautions.
Is the endometrial cancer warning gone?
No. According to the announcement, it remains on systemic estrogen-only products.
Does this change anything in Canada?
Not automatically. Canadian product labels are reviewed separately. Your physician or pharmacist can explain the current Canadian label for any product.
I live in Richmond. Who should I talk to about menopause symptoms?
Start with your family doctor or another physician, and bring a list of your symptoms, current medications and family history.
This article is general education from Richmond Anti-Aging Clinic in Richmond, BC, and does not replace individual medical advice.
