The FDA Finally Removed the Black Box Warning on Hormone Therapy — Here’s What Women Deserve to Know

By: Dr. Sarah Berg, Founder of Selfority

In a long-awaited move, the FDA has removed the black box warning from many of the hormonal therapies used in menopause.
If you’ve ever looked at an HT package insert and felt your heart race at the list of risks — stroke, breast cancer, heart attack, blood clots, dementia — you’re not alone. That ominous black box has shaped two decades of fear, avoidance, and confusion.

But here’s the part that might surprise you:

The science didn’t suddenly change.
The interpretation finally did.

This update is progress — but it isn’t a cure-all. And unless we talk honestly about what this means, it risks becoming yet another moment where women are left confused between headlines, influencers, and half-understood science.

Let’s make sure that doesn’t happen.

Why the Black Box Warning Was Problematic from the Start

The black box originated from the initial 2002 Women’s Health Initiative (WHI) results — which were widely misinterpreted, oversimplified, and applied too broadly.

That warning:

• did not reflect younger, healthy symptomatic women

• lumped older, outdated formulations together with modern bioidentical options

• treated all estrogen the same

• treated all progestogens the same

• ignored timing, route, and dose

• overstated risks without context

The result?
A generation of women — even excellent candidates — refused hormone therapy because the black box felt like a red flag.

Clinicians knew the nuance, but the packaging did not.

So yes, removing the black box is overdue.
But it also invites a new kind of misinterpretation:
“If the warning is gone, HT must be completely safe.”
Not true.

What the Menopause Society (and the Best Current Evidence) Actually Says

The Menopause Society has been clear for years: hormone therapy is the most effective treatment for vasomotor symptoms and has multiple established benefits when used appropriately.

Hormone Therapy is appropriate for:

• Moderate–severe hot flashes and night sweats

• Vaginal dryness, pain with sex, urinary symptoms (GSM)

• Early menopause, POI, or surgical menopause

• Bone protection in early menopause

• Healthy women under 60 or within 10 years of their final menstrual period

Areas with promising — but not certain — benefits:

• Sleep stability

• Mood regulation (especially in perimenopause)

• Cardiovascular protection when started early (“timing hypothesis”)

• Positive effects on body composition and metabolism

• Possible cognitive benefits (still under study)

Areas where data remains limited or inconclusive:

• Dementia outcomes

• Breast cancer risk differences between progestogens

• Optimal therapy duration

• Late initiation (over age 60)

• Long-term cardiometabolic data across diverse populations

• Individualized dosing by genetics or metabolism

And this is where the real story sits:
We still don’t know enough, because women’s midlife health has been underfunded and under-researched for decades.

A Quick, Fascinating Look at How Hormone Therapy Evolved

We didn’t begin with the elegant transdermal estradiol patches or micronized progesterone we use today. Hormone therapy’s roots stretch back nearly a century:

1. Injected estrogens (1940s–50s)

Powerful, but unpredictable and inconvenient.

2. Conjugated equine estrogens (Premarin)

Extracted from pregnant mare urine — the first scalable, stable estrogen.
Not bioidentical, but groundbreaking for its time.

3. Synthetic progestins

Not invented because they were superior — but because natural progesterone broke down too quickly when swallowed.

4. The rise… then the crash

Through the 80s and 90s, HT was widely embraced.
Then the WHI reported increased risks — and hormone therapy prescriptions dropped by more than 70%.

5. Modern formulations

We now have:

• Transdermal estradiol

• Micronized progesterone

• Low-dose combinations

• SERMs

• TSECs

• Ultra-low-dose vaginal estrogen

These therapies are safer, more targeted, and better matched to human physiology.

And yet, the old black box warning applied to all of them equally — which was scientifically inaccurate.

Why Removing the Warning Is Progress — and Why It Requires Caution

Removing the black box does not mean hormone therapy is now risk-free.
It doesn’t mean every woman should take it.
And it certainly doesn’t mean social media claims about anti-aging or “weight-loss magic” are validated.

What the removal actually means is this:

👍 Women who are good candidates may finally feel less fear
👍 Clinicians may feel less constrained prescribing a safe, effective therapy
👍 Pharma may invest in better formulations, SERMs, and alternatives
👍 The messaging will finally begin to reflect the nuance clinicians already use

But:

⚠️ This change may fuel oversimplified “HT is safe for everyone” messages
⚠️ It may embolden misleading marketing from the compounded hormone industry
⚠️ It may lead to overconfidence in areas where research is still emerging

Removing the warning doesn’t remove the nuance.
And nuance is exactly where women’s health has been neglected.

What Women Need Most Now: Clear, Evidence-Based Education

The real issue was never that hormone therapy was “dangerous.”
The issue is that we gave women:

• a complex therapy

• with evolving data

• boxed in outdated warnings

• and without the research they deserved

The FDA lifting the black box is a step — a good one — toward modern, evidence-based menopause care.

But the responsibility now shifts to clinicians, educators, researchers, and industry leaders to communicate clearly.

Women deserve:

• clarity over fear

• evidence over hype

• options over confusion

• and funding for research that finally centers midlife health

Hormone therapy can be a fantastic tool.
A powerful tool.
But it’s still a tool we don’t fully understand — because we haven’t invested enough time and science into women’s health.

This decision opens the door.
Now it’s time for the science, the policy, and the education to follow.

If You Want to Learn More

Selfority provides clear, evidence-based education on hormone therapy and the full menopause transition — no fear, no hype, no confusion.

➡️ Explore Menopause, Explained
➡️ Or start with Menopause, Essentials

Women deserve to understand their bodies — confidently, compassionately, and without misinformation.