Why the Recent FDA Label Change on Estrogen Matters for Women’s Health

I’m passionate about giving women clear, evidence-based information about hormonal health—especially around the menopause transition. So this week’s announcement from the Food and Drug Administration (FDA) is a big deal, and I want to walk you through what it means, why it matters, and how it plays into my approach to my patients’ hormone replacement therapy (HRT).

What changed?
The FDA has initiated the removal of the so-called “black box” warnings (the strongest safety warning a medication can carry) from many estrogen-containing hormone replacement therapies used for menopause.

Specifically, the agency is asking manufacturers to revise labels and remove references to three major prior concerns:

1.     Cardiovascular disease (heart attacks, strokes)

2.     Breast cancer

3.     Probable dementia (cognitive decline)

However—one warning remains: for endometrial (uterine) carcinoma when estrogen is used alone in a woman who still has a uterus (i.e., without a progestogen).

Why were the warnings removed?
Here’s the short version: the original warnings were rooted in the landmark Women’s Health Initiative (WHI) data from the early 2000s, which found increased risks of these outcomes among older post-menopausal women (average age ~63) using the formulations studied. But since then we’ve learned several things:

·       Timing matters: numerous newer analyses show that when hormone replacement therapy (HRT) is initiated within 10 years of menopause onset or before age 60, the risk profile is very different (1).

·       Formulation and route matter: Many modern HRT formulations differ (dose, hormone type/progestogen pairing, delivery method) from those studied in WHI.

·       Risk may have been overstated: The likely generalized fear-based labeling discouraged many women who might have benefited, even when their individual risk was low. The FDA summary says “women who start HRT within 10 years of onset of menopause … appear to have a reduced risk of mortality and other complications.”

In other words: the science now supports a more nuanced, individualized approach rather than a blanket “avoid hormone therapy” stance. And the black box warning was acting more like a barrier than a guide.

What this means in practice
For women in early to mid-menopause with bothersome symptoms (hot flashes, night sweats, vulvovaginal atrophy, bone-loss risk), this change means HRT may be less stigmatized and more accessible—when used thoughtfully.

I still adhere to best practice:

·       Initiation timing: ideally within 10 years of menopause or age < 60 for systemic therapy

·       Individual risk assessment: personal/family history of breast cancer, clotting disorders, liver disease, comprehensive lab work and close monitoring

·       Dose, formulation & route are all tailored to the patient’s specific symptoms and medical needs

An important reminder about the one warning that remains:
If you still have your uterus, using estrogen alone (unopposed) can stimulate the endometrial lining and raise risk of endometrial carcinoma, or cancer of the uterine lining. That warning is not removed. So in my practice:

·       For women with a uterus using systemic estrogen, we always add a progestogen (or use a combined estrogen-progestogen product) to protect the uterus.

·       Alternatively, if a woman has had a hysterectomy, we may consider estrogen alone.

Why I’m confident in this change
Clinically, I have seen how women are under-treated for menopause symptoms and preventive health simply because of fear driven by labels rather than data. Removing the black box is not a blanket “hormone therapy for everyone” message—but rather a correction of outdated fear. With proper patient selection, monitoring and individualized care, estrogen (and combined HRT) can be a safe, effective component of optimizing mid-life wellness—relieving symptoms, supporting bone health, sleep, mood and long-term health, such as reduction of heart disease (the number one killer of women), dementia, and osteoporotic bone fractures.

In summary, the right hormone plan, in the right person, at the right time, can be life-changing. I’m excited that the FDA has decided to move forward with evidence-based data.

In good health,

Gina

Disclaimer: This blog post is for patient education and does not substitute individualized medical advice.

References:

(1)  Makary et al. Updated labeling for menopausal hormone therapy. JAMA Network. doi: 10.1001/jama.2025.22259

(2)  www.hhs.gov Fact Sheet: FDA initiates removal of warnings from menopausal hormone replacement therapy products. Nov 10, 2025