The FDA Removed the Black Box Warning on Menopause Hormone Therapy: Here’s What That Actually Means

Feb 10
4 min read

If you’ve ever picked up vaginal estrogen or a hormone therapy patch from the pharmacy, unfolded that giant paper insert, and thought:

“Wait… is this trying to kill me?”

You’re not alone.

On November 10, 2025, the U.S. Food and Drug Administration announced it would initiate removal of the boxed (“black box”) warning language that has lived on menopause hormone therapy labels for more than two decades—language referencing risks like cardiovascular disease, breast cancer, and probable dementia. (U.S. Food and Drug Administration)

This is a big deal—not because it suddenly makes hormone therapy right for everyone, but because it may finally stop a lot of fear-based decision-making that was driven by outdated, overly broad labeling. (U.S. Food and Drug Administration)

Let’s break it down in plain language.

What is a “black box warning,” really?

A boxed warning is the FDA’s strongest type of medication warning—the “pay attention or else” category. It’s typically reserved for risks that are serious, potentially life-threatening, or require careful monitoring.

So when menopause hormone therapies carried boxed warnings for years (including local vaginal estrogen, which has minimal systemic absorption), it wasn’t surprising that many women felt panicked and opted out altogether. (Let's Talk Menopause)

Why did we have this warning in the first place?

You can’t talk about this without talking about the Women’s Health Initiative (WHI) trial results that landed in 2002 and changed everything.

In the combined estrogen + progestin arm (for women with a uterus), the WHI reported increased risks (like CHD events, stroke, pulmonary embolism, and invasive breast cancer) and some benefits (like fewer hip fractures). (JAMA Network)

Those results were widely interpreted as “hormones are dangerous,” full stop—despite important context, including the age of participants and the fact that the study was evaluating hormone therapy as primary prevention for heart disease (not symptom relief started near menopause onset). (Reuters)

What changed in 2025?

After years of additional research and advocacy, the FDA reviewed the evidence and announced it would work with manufacturers to remove references in labeling to risks of cardiovascular disease, breast cancer, and probable dementia. (U.S. Food and Drug Administration)

A key nuance: the FDA said it is not seeking to remove the boxed warning related to endometrial cancer risk for systemic estrogen-alone products (which matters for women with a uterus). (U.S. Food and Drug Administration)

And the big “why” here is timing + nuance: later evidence supports that starting hormone therapy earlier (often described as before age 60 or within ~10 years of menopause onset) generally has a different risk profile than starting much later. (The Menopause Society)

✨ Top 3 takeaways (the version you can actually use)

1) This change is about labeling and fear, not “hormones for everybody”

The removal is meant to correct a misleading, overly broad warning that scared many women away from treatments that could meaningfully improve quality of life—especially for symptoms like hot flashes and genitourinary symptoms (dryness, urinary urgency/frequency). (Let's Talk Menopause)

But it does not mean hormone therapy is automatically appropriate for every person, at every age, with every medical history.

2) The WHI wasn’t “fake”—but it was misapplied

The WHI findings are real. The issue is how the results got translated into a universal message, without enough attention to:

participant age and baseline risk
formulation/dose/route (oral vs transdermal)
why the therapy was being used (prevention vs symptom treatment)

In other words: the labeling became a blunt instrument for a nuanced decision. (U.S. Food and Drug Administration)

3) Hormone therapy is part of a midlife toolkit, not the entire toolkit

Even if hormone therapy is a great choice for you, it should live inside a broader plan:

cardiovascular risk factors (blood pressure, lipids, diabetes)
sleep evaluation (including sleep apnea when indicated)
mood/anxiety support when needed
strength training, nutrition, alcohol moderation, stress care

The win here is that we can have better conversations—without patients being terrified by a boxed warning that doesn’t match the nuance of modern care. (The Menopause Society)

Quick FAQ

Does this mean vaginal estrogen is safer now?

Vaginal estrogen didn’t suddenly “become” safer—what’s changing is the labeling that implied risks that weren’t supported for low-dose local therapy. (Let's Talk Menopause)

Does this mean hormone therapy prevents heart disease or dementia?

No “panacea” messaging, please. Some data support potential benefits when started at the right time for the right patient, but it’s not a universal prevention strategy—especially if underlying risk factors aren’t addressed. (AP News)

When will labels change?

The FDA indicated it is working with companies to update labeling as part of this initiative (timelines may vary by product/manufacturer). (U.S. Food and Drug Administration)

The bigger point (and why I’m 10-toes-down about Revival)

This FDA decision is a win for women’s health because it reduces fear and opens the door for more women to ask, “Could this help me?” without being shut down by outdated labeling. (Reuters)

But the next step is what matters most: personalized, whole-person care—the kind that doesn’t treat hormones like a cure-all or treat you like a checklist.

That’s exactly why I’m building Revival Women’s Health—a medical home for midlife women where we can talk about symptoms, risks, goals, and options with nuance (and zero scare tactics).

If you’re in the Atlanta area—or you love someone who is—send them my way. And if you’re on the waitlist, stay close. The next chapter is coming.