The FDA Removes the “Black Box” Warning on Menopausal Hormone Therapy: What It Really Means for Women
November 11, 2025
The FDA Removes the “Black Box” Warning on Menopausal Hormone Therapy: What It Really Means for Women
By Susan Merenstein, Pharmacist/Hormone Expert – The Vital Health Pharmacist
Note: “Progestogen” in manufactured MHT refers to Provera, the synthetic manmade molecule, which is NOT the same as bioidentical/human identical hormone Progesterone.
“Estrogen” refers to horse derived estrogen and is made up of mostly estrone.
Human identical estrogen is Estradiol, Estrone, or Estriol.
Hormone imbalances can start in younger women.
For over two decades, millions of women have been told that hormone therapy for menopause carries dangerous risks. Those bold black box warnings on estrogen and estrogen–progestogen prescriptions created fear and confusion, discouraging many from seeking treatment for debilitating hot flashes, night sweats, and other symptoms that impact quality of life.
In November 2025, the U.S. Food and Drug Administration (FDA) announced a long-overdue change: it is removing the black box warning from menopausal hormone therapy (MHT) products. This is a major step toward restoring balance and clarity to women’s health.
What Changed
The FDA’s update reflects decades of research showing that hormone therapy can be safe and beneficial when used appropriately—particularly when started near the onset of menopause.
Here’s what’s new:
- The boxed warning for heart disease, stroke, breast cancer, and dementia is being removed for most systemic hormone products.
- The warning for endometrial cancer remains in place for women with a uterus using estrogen alone (unopposed estrogen).
- New labeling will focus on individualized care, encouraging shared decision-making and consideration of each woman’s age, timing since menopause, health risks, and goals.
Why It Matters
The original black box warning was based largely on early interpretations of the Women’s Health Initiative (WHI) study in the early 2000s—a study that mostly involved women in their mid-60s, long past menopause. Over time, scientists realized that age and timing matter.
Modern evidence shows a “window of opportunity”:
Starting hormone therapy within 10 years of menopause or before age 60 offers the best balance of benefits and risks.
When used correctly, MHT can:
- Reduce hot flashes, night sweats, and sleep disturbances
- Support bone density and prevent fractures
- Improve vaginal health and sexual comfort
- Possibly reduce cardiovascular risk when started early
The Balance of Benefits and Risks
Like any therapy, hormone treatment isn’t one-size-fits-all. Risks can include blood clots, stroke, or breast cancer—but these depend on age, personal health, family history, formulation, and route (oral, transdermal, or vaginal).
The FDA’s action doesn’t mean MHT is risk-free—it means that the science now supports a more balanced, individualized approach rather than blanket fear.
💬 What This Means for You
If you’re struggling with menopause symptoms, this is the moment to revisit your options.
Talk with your pharmacist and healthcare provider about:
- When your menopause began
- Whether you still have your uterus (which determines if you need a progestogen)
- Your personal and family medical history
- Which type, dose, and route of hormone therapy might fit your needs
Remember: you deserve relief, balance, and vitality—and the science now supports that.
A New Era for Women’s Health
As a holistic pharmacist, I see this change as both scientific progress and a chance to empower women to take charge of their health. The removal of the black box isn’t just a regulatory decision—it’s a signal that women’s health care is finally catching up with the evidence.
If you’ve been told to “just live with” menopause symptoms, it’s time to start a new conversation.
I have been consulting with women for over 25 of my 45 years of pharmacy practice and helping them achieve quality of life and hormone balance.
You can schedule a consultation by clicking here
Visit VitalHealthPharmacist.com to learn more about hormone balance, functional wellness, and natural support options.
My motto: “Be aware of your symptoms, get educated, and take a pro-active role in your health!”
Susan Merenstein, Holistic Pharmacist/Hormone Expert
Holistic Health Apothecary
Murray Avenue Apothecary / LabNaturals, Inc.
📞 412-586-4678 | 🌐 www.VitalHealthPharmacist.com