BHRT for Women Just Changed: Here’s What Everyone Should Know
- Gary M. Rudashevsky, NP
- Dec 10, 2025
- 4 min read
The FDA Removed the “Black Box” Warning on Hormone Therapy: Should You Reconsider Treatment?
Key Takeaways
The FDA is removing the old “black box” warning from many menopausal hormone therapy products because the science has changed. (1)(2)
Women who start hormone therapy near the start of menopause often have lower risks and stronger benefits. (2)
The update does not mean hormone therapy is risk-free. It means the warning will now reflect current research. (1)
Women in the Edina area can now make clearer choices about hormone care with accurate information.
Every woman still needs a personal plan based on age, symptoms, and medical history.
What Exactly Did the FDA Change?
The FDA decided to remove the long-standing “black box” warning from many estrogen-based menopausal hormone therapy products. (1)
This warning was put in place more than 20 years ago after early studies raised concerns about risks such as breast cancer, stroke, and blood clots. (2)
After reviewing updated evidence, the agency found the warning was no longer accurate for many women and needed to be replaced with more precise, modern guidance. (1)
Why Did the FDA Remove the Old “Black Box” Warning?
Newer research shows that timing matters. Women who start hormone therapy before age 60 or within about 10 years of menopause have a different risk profile than women who start much later. (2)
The old warning treated all hormone therapy the same, even though not all products carry the same level of risk. Local low-dose vaginal estrogen, for example, has very low systemic absorption. (1)
After reviewing the science, the FDA determined the broad warning was misleading and should be updated to reflect current evidence. (1)(2)
Does This Mean Hormone Therapy Is Completely Safe for Everyone Now?
No. Hormone therapy still has risks, and not every woman is a good candidate.
The FDA is not saying hormone therapy is risk-free. Instead, they are correcting the outdated warning so women and providers can make decisions based on today’s research. (1)
A full medical review is still important, especially for women with a history of breast cancer, clotting disorders, or heart disease.
Which Women May Benefit the Most From This Update?
Women who may benefit include those who:
are entering perimenopause or early menopause
are under 60
experience hot flashes or night sweats
have sleep problems
notice vaginal dryness or discomfort
feel mood or energy changes
want support for bone health
The FDA’s change helps these women get clearer information about their options. (1)(2)
How Does Timing Affect Safety and Results of BHRT for Women?
Timing is one of the most significant factors in hormone therapy. Starting BHRT for Women in early menopause (or close to the last menstrual period) is linked with lower risks and stronger benefits. (2)
Starting therapy many years after menopause may come with higher risks.
This is called the “timing hypothesis,” and it is a major reason the FDA updated the warning. (2)
What Does This Change Mean for Women Near Edina?
A: Women in and around Edina now have more accurate information to guide conversations with a hormone provider. Instead of avoiding treatment due to fear of an outdated warning, women can explore options based on current research and personal health factors.
This update gives women clearer choices for managing symptoms like hot flashes, sleep problems, mood changes, and vaginal dryness. It also supports personalized care, which is common in hormone-focused clinics in the Edina area.
How Does Hormone Therapy Work Today Compared to the Past?
Hormone therapy today is more personalized.
Providers can adjust:
dose
route (pill, patch, cream, pellet, or vaginal form)
timing
monitoring schedule
The goal is to match each woman with the safest and most effective option for her body. This fits well with the FDA’s updated guidance. (1)
What Should You Discuss With a Hormone Provider Now?
It helps to talk about:
your age and menopause timing
your symptoms
your family and personal medical history
breast cancer risks
blood clot risks
whether you still have your uterus
whether you need progesterone
whether low-dose vaginal estrogen or systemic estrogen is right for you
how often you should follow up
These steps help you and your provider create a safe, personalized plan.
FAQ
Q: What did the FDA officially change about hormone therapy?
A: The FDA is removing the old “black box” warning from many menopausal hormone therapy products and replacing it with updated guidance based on current research. (1)(2)
Q: Is hormone therapy safer now for women in the Edina area?
A: Hormone therapy can be safe for many women when started near menopause and monitored by a trained provider. Safety depends on timing, dose, and medical history.
Q: Do women still need progesterone if they take estrogen?
A: Yes. Women who still have a uterus need progesterone with systemic estrogen to protect the uterine lining.
Q: Is vaginal estrogen safer than full-body estrogen?
A: Yes. Low-dose vaginal estrogen has far lower systemic absorption and a different risk profile. (1)
Q: Can hormone therapy help with sleep, mood, hot flashes, or dryness?
A: Yes. Hormone therapy remains the most effective treatment for hot flashes and vaginal symptoms and may help with sleep and mood. (2)
Q: Should women over 60 start hormone therapy?
A: Women over 60 or more than 10 years past menopause need a more detailed risk review. Some can still use hormone therapy, but timing matters.
Q: Does this update include bioidentical hormone therapy (BHRT)?
A: The FDA guidance applies to FDA-regulated menopausal hormone therapies. Personalized BHRT still depends on dose, form, and provider oversight.
Ready to Talk About Your Options?
If you are having symptoms and want to understand whether hormone therapy is right for you, we are here to help.
Our team will walk you through testing, timing, safety, and your full treatment choices.
Call us: (952) 225-5400
Email us: inquiries@medicalsp.net
You deserve clear answers and care that fits your life. We are ready when you are.
Sources
U.S. Food and Drug Administration (FDA) – “HHS Advances Women’s Health: Removes Misleading FDA Warnings on Hormone Replacement Therapy”https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
U.S. Department of Health & Human Services (HHS) – “FDA Initiates Removal of ‘Black Box’ Warnings From Menopausal Hormone Replacement Therapy Products”https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html
