What did the FDA change?
On November 10, 2025, the U.S. Food and Drug Administration announced it is removing the “black box” warning from many estrogen and estrogen-progestogen products used for menopausal hormone therapy (HRT). This decision reflects newer research showing that risks once thought to apply to all hormone therapy actually vary by age, timing, and formulation.
Why was there a black box warning in the first place?
The warning was added in the early 2000s after flawed studies suggested increased risks of breast cancer, heart disease, blood clots, and stroke, especially in older women who started hormone therapy long after menopause. Those findings led to widespread caution and in most cases avoidance of HRT even for patients who might benefit from it.
Why did the FDA remove the warning now?
Newer studies and expert reviews show that for many patients, particularly those under 60 or within 10 years of menopause, the benefits of hormone therapy can outweigh the risks.
The FDA determined that the blanket black box label overstated risks for many products and discouraged appropriate use.
Does this mean hormone therapy is completely safe?
As with any treatments and medications, hormone therapy still has potential risks. The right choice depends on a patient’s health history, family history, and timing. Some products will still carry warnings (for example, taking estrogen without also taking progesterone for women with a uterus due to endometrial cancer risk). It’s important to make decisions with your healthcare provider or pharmacist.
How does this affect current or new prescriptions?
You may notice updated medication guides and packaging as labels are revised.
If you’re already taking HRT, don’t make changes on your own. Instead, check in with your doctor or pharmacist to review whether your current therapy is still right for you.
What are the benefits of hormone therapy?
For many patients, HRT can:
Relieve hot flashes, night sweats, and vaginal dryness.
Improve sleep and mood.
Help prevent bone loss after menopause.
When used appropriately, HRT can greatly improve quality of life.
How can my pharmacist help?
Your pharmacist can:
Review your medications for interactions.
Help you choose between oral, patch, or local/topical (vaginal) options.
Provide privacy, education, and judgment-free support.
Coordinate with your healthcare provider for refills and monitoring..
The FDA’s change recognizes that hormone therapy isn’t one size fits all but for the right person, at the right time, it can be both safe and effective. Remember to always talk with your healthcare team before starting or stopping any hormone therapy.
About RevanRx
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We hope to increase patient adherence and access to care for those who would otherwise not feel comfortable receiving medications or medication counseling in a public setting, avoiding embarrassing public conversations, misgendering, or refusal of service. Visit us at Revanrx.com and like us on Facebook.