FDA Removes Black Box Warnings on Hormone Therapy: What This Means for Women—and How BHRT Can Help
A new chapter for women’s health
In a landmark move for women’s health, the FDA announced on November 10, 2025, that it will remove the decades-old black box warnings from most menopausal hormone therapy (HRT) products. These warnings, which were first added in the early 2000s, have shaped two generations of women’s care, often discouraging women and clinicians from considering hormone therapy, even when menopausal symptoms were severe.
Now, based on years of updated research, including long-term follow-up from the Women’s Health Initiative (WHI) and subsequent studies, the FDA acknowledges that the previous warnings were overly broad, outdated, and didn’t reflect what we now know: when used appropriately, bioidentical hormone therapy can be both safe and profoundly beneficial for many women. The agency is directing manufacturers to update labels to better reflect individualized risks and benefits, emphasizing that for women initiating therapy before age 60 or within 10 years of menopause, the benefits often outweigh the risks.
Why Were the Warnings There in the First Place?
In 2002, the Women’s Health Initiative (WHI) released early results suggesting increased risks of breast cancer, stroke, blood clots, and heart disease for women taking menopausal hormone therapy.
What most people don’t know is:
The average participant in the WHI was 63 years old, well beyond menopause onset (which in the US is at the average age of 52) and was far from the typical starting age for BHRT today.
The participants were given synthetic hormones (conjugated equine estrogens and medroxyprogesterone acetate) that are rarely used today.
Many participants in the study had pre-existing risk factors that skewed the results.
Follow-up studies, including 20+ years of WHI data, showed a much more nuanced picture: risks are lower and benefits clearer when therapy starts closer to menopause onset—but the black box warnings stayed until now.
What the FDA’s Decision Actually Means
By removing the black box warnings, the FDA is signaling an important truth: Hormone therapy is not universally dangerous. Its risks depend on:
Age
Timing (how close to menopause you are when you start)
Dose
Type of hormone
Route of delivery (oral vs. patch vs. topical)
Health history
Family history
For healthy women under age 60 or within 10 years of menopause, randomized studies show that bioidentical hormone therapy can reduce overall mortality and chronic disease risks, with benefits often outweighing potential risks. The FDA will keep one boxed warning: Unopposed estrogen can increase the risk of endometrial cancer in women with a uterus. (This is why progesterone is added for protection.) Beyond that, labels will now reflect the more accurate, individualized risk profile of modern BHRT.
Is HRT Safe Now? Here’s the Real Answer
Hormone therapy can still have risks for some, but they’re not one-size-fits-all, and they are far less concerning for the majority of women than previously believed. Today’s evidence, including from the North American Menopause Society and recent FDA reviews, shows that appropriate BHRT can:
Dramatically improve hot flashes and night sweats (the most effective treatment available)
Improve sleep and mood
Reduce brain fog
Improve sexual health
Help maintain bone density and reduce fracture risk
Support long-term vitality, including potential cardiovascular protection when started early enough
And when used in the right population, it does not significantly raise breast cancer risk overall, especially with transdermal estrogen and micronized progesterone combinations—though monitoring remains key.
Where BHRT Fits Into the Picture
You’re likely hearing a lot about BHRT — Bioidentical Hormone Replacement Therapy. These hormones are chemically identical to what your ovaries once produced, which many women find results in better symptom relief and fewer side effects.
BHRT comes in two forms, and both have an important place in modern menopause care:
1. FDA-approved bioidentical hormones
(estradiol patches, gels,creams, vaginal products, and oral micronized progesterone)** These are excellent, well-studied options with consistent dosing — our first-line choice for the majority of women.
2. Compounded BHRT (creams, troches, pellets, capsules, etc.)
Compounded hormones are personalized by skilled compounding pharmacists to meet your exact dose, delivery method, or combination that isn’t commercially available.
Ideal when a woman needs a non-standard dose, has allergies to excipients in commercial products, prefers transdermal or sublingual routes not offered by manufacturers, or wants physiologic estrogen + progesterone ratios in a single formulation.
When prepared by an accredited compounding pharmacy (PCAB/ACHC certified) and prescribed with proper monitoring, compounded BHRT has an outstanding track record in clinical practice and can offer superior symptom control and tolerability for certain patients.
At Wildfire Wellness we use both FDA-approved and high-quality compounded bioidentical hormones — whichever option (or combination) best fits your unique physiology, symptoms, and lifestyle.
Why BHRT (Including Compounded) Can Be Such a Game-Changer
When prescribed and monitored by an experienced provider, bioidentical hormones — whether FDA-approved or expertly compounded — offer distinct advantages:
Exact molecular match to your body’s own hormones
Ability to fine-tune dosing down to the microgram (impossible with most commercial products)
Lower clotting risk with transdermal and sublingual routes
Often superior relief of hot flashes, sleep disturbance, mood, libido, and brain fog compared with older synthetic hormones
Growing body of observational and clinical practice data showing favorable breast and cardiovascular outcomes when started at the right time in menopause
Compounding isn’t “less safe” — it’s simply a different regulatory category. The key is working with a knowledgeable clinician and a reputable, accredited pharmacy — exactly what we do every day at Wildfire Wellness.
How Wildfire Wellness Approaches BHRT
At Wildfire Wellness, hormone therapy is never a one-size-fits-all solution. Our approach prioritizes:
✔ Root-cause evaluation
We look at hormones and the systems that influence them—thyroid, gut health, stress response, inflammation, nutrient status, and more.
✔ Evidence-based treatment
We use FDA-approved bioidentical hormones whenever possible and base treatment decisions on modern research, not outdated guidelines.
✔ Personalized dosing and monitoring
We tailor therapy to your physiology, symptoms, and goals—adjusting as your body changes.
✔ Whole-person wellness support
Your plan may include nutrition guidance, stress management, sleep support, and targeted supplements to support long-term health.
How Do You Know If BHRT Is Right for You?
You may be a strong candidate if you're experiencing:
Hot flashes / night sweats
Insomnia
Brain fog or difficulty concentrating
Mood swings or irritability
Vaginal dryness or discomfort
Weight changes
Loss of muscle or bone density
Fatigue or low motivation
If these symptoms are impacting your life, the FDA’s updated stance is a signal that it’s time to revisit hormone therapy with confidence—discuss your personal risks (like family history or smoking) with your provider.
Why This Policy Change Matters
The FDA’s decision represents a long-overdue shift in how menopause care is approached in the U.S.
It means:
More informed choices
More individualized care
Less fear and stigma
More women accessing therapies that can truly improve quality of life
If you’ve ever been told “HRT is too risky” or “you just need to tough it out,” the landscape has changed—and so can your options.
Ready to Feel Like Yourself Again?
If you're in New Jersey, Connecticut, or Florida, Wildfire Wellness offers personalized functional medicine and BHRT support through convenient telehealth.
Together, we’ll explore:
Your symptoms
Your hormone levels (when appropriate)
Your personal risk profile
Your wellness goals
And your full menu of treatment options
Schedule a Consultation Today below or call us to get started at 609-678-5329!
Your vitality is worth it.