Why the FDA Is Removing the Black-Box Warning on Hormone Therapy — And What It Means for You

Written by Kari Waddell, FNP, MSCP

Introduction

On November 10, 2025, the U.S. Food & Drug Administration (FDA), together with the Department of Health & Human Services (HHS), announced a landmark change: the agency is initiating the removal of the “black-box” warning from many hormone replacement therapy (HRT) products used to treat menopausal symptoms. U.S. Food and Drug Administration+2HHS+2

This is a major moment in women’s health — especially for those considering or already using hormone therapy for menopause-related symptoms. Below, I’ll walk you through why this change is happening, the science behind it, who may benefit most, and key take-home points for informed decision-making.

A Little History: Why Was There a Black-Box Warning in the First Place?

1. Origins in the WHI Study

   • The black-box warning dates back to data from the Women’s Health Initiative (WHI), published in the early 2000s. That large randomized trial raised red flags about elevated risks of breast cancer, stroke, heart disease, dementia, and blood clots in women on combined estrogen-progestin therapy. Forbes+1

   • Notably, the average age of participants in the WHI was 63, which is well beyond the average age when women enter menopause (early 50s), leading to important questions about generalizability. Forbes+1

   • Also, the hormone formulations used in WHI (e.g., conjugated equine estrogens + medroxyprogesterone) differ from many of the more modern HRT options. Forbes

2. Impact of the Warning

   • After the black-box was added, HRT use dropped dramatically because the warning scared many clinicians and patients. Healthline+1

   • Over time, this may have contributed to undertreatment of menopausal symptoms as well as missed opportunities for benefits in quality of life, bone health, and potentially other long-term health outcomes.

What New Evidence Has Changed the Picture

Recent years have brought a much more nuanced understanding of risks and benefits — especially when therapy is started thoughtfully. Key points from the FDA’s review and public communications:

1. Comprehensive Evidence Review

   • The FDA convened an expert panel (July 2025), engaged in a public comment period, and re-analyzed decades of scientific literature. U.S. Food and Drug Administration+2Forbes+2

   • Importantly, they looked at more modern data, including younger women (e.g., those who initiate HRT within 10 years of menopause onset or before age 60). U.S. Food and Drug Administration+1

2. Revised Risk Estimates

   • Based on their review, the FDA is requesting that manufacturers remove references to cardiovascular disease, breast cancer, and probable dementia risk from the black-box warnings of many HRT products. U.S. Food and Drug Administration

   • However, they are not removing the warning for endometrial cancer in systemic estrogen-only products (i.e., for women who still have a uterus), so some caution remains. HHS

   • They are also removing the blanket recommendation to “use the lowest effective dose for the shortest duration” in the black-box, leaving more room for individualized decision-making. American Med Spa Association

3. Benefits Highlighted

   • The FDA’s fact sheet emphasizes that, for many women, the benefits of HRT outweigh the risks — particularly when started early: within 10 years of menopause onset or before age 60. HHS+1

   • Reported benefits include: reduced risk of all-cause mortality, fewer fractures, and potentially lower risks of cognitive decline and Alzheimer’s disease. HHS

   • A reanalysis of multiple trials (30 trials, ~26,700 women) suggested no increased cancer-related mortality; in some cases, HRT was associated with decreased mortality. HHS

4. Regulatory and Access Updates

   • Alongside the label change, the FDA is approving a generic version of Premarin (conjugated estrogens), which may improve affordability and access. U.S. Food and Drug Administration

   • Also approved: a non-hormonal therapy for moderate-to-severe vasomotor (hot-flash) symptoms, providing more treatment options. U.S. Food and Drug Administration

What This Means for Patients — Especially in a Clinical Practice Setting

As a clinician or patient in a women’s health / HRT practice, here’s how to think about this change practically:

1. A Shift Toward Individualized Care

   • This isn’t a blanket endorsement of HRT for everyone. Rather, the removal of the black-box signals a move toward personalized risk-benefit conversations. Forbes

   • Factors like age, time since menopause, health history, and personal values should shape decision-making.

2. Better Communication Between Clinicians and Patients

   • With the black-box gone (for many risks), clinicians now have more room to explain nuanced evidence rather than relying on fear-based messaging.

   • It’s an opportunity to ensure patients understand both the symptom-relief benefits (e.g., hot flashes, sleep, bone health) and the updated risk profiles.

3. Risk Still Exists — But Context Matters

   • The risk of endometrial cancer (for systemic estrogen-alone therapy in women with a uterus) remains, so that caution is preserved. HHS That said, we know how to mitigate this risk with progesterone or other progestin.

   • Not all HRT is the same: dose, route (pill vs patch vs local), and formulation affect risk. For instance, low-dose vaginal estrogens — which have minimal systemic absorption — are considered safer from many perspectives. Science News+1

   • Duration of therapy, ongoing monitoring, and revisiting therapy decisions over time remain important.

4. Potential Public Health Impact

   • Because the black-box historically discouraged many women (and providers) from using HRT, this change might help restore access to effective therapy for symptomatic menopausal women. U.S. Food and Drug Administration

   • It may also reduce stigma, misinformation, and “one-size-fits-all” fear, enabling more women to make informed, evidence-based choices.

Risks, Criticisms, and Controversies to Be Aware Of

It’s important to acknowledge that not everyone agrees with the removal — and there are valid discussion points.

• Critique of the Process: Some have raised concerns about the expert panel used by the FDA, noting potential conflicts of interest and lack of transparency. AP News

• Long-Term Data Still Evolving: While newer analyses are promising, not all long-term risks are fully resolved, especially in diverse populations or with different formulations.

• Not a Preventive Cure-All: The FDA emphasized that HRT is not being positioned as a primary prevention drug for heart disease or Alzheimer’s — its main indication remains symptom control.

• Patient Selection Matters: For women with certain risk factors (e.g., history of hormone-sensitive cancer, thromboembolic disease), HRT may still require careful evaluation or may be contraindicated.

Key Take-Home Messages

1. The FDA’s removal of the black-box warning is a science-driven update, not a blanket “safe for everyone” stamp.

2. For many healthy women under ~60 or within 10 years of menopause onset, HRT may offer significant benefits with lower relative risk than previously framed.

3. Decision-making should be highly individualized — considering symptoms, risks, goals, and personal values.

4. There remain real, but more contextualized, risks; ongoing monitoring and shared decision-making remain central.

5. This regulatory change may reduce barriers (cost, fear, misinformation) and open the door for more conversations about quality-of-life management in menopause.

How We Approach This in Our Practice

At Radiant Health for Women, we see this FDA change as a win for patient-centered, evidence-based care. Here’s how we’re integrating it into our clinical approach:

• During consultations, we frame HRT not just as a “hot-flash treatment,” but as a holistic tool to support quality of life, bone health, mood, and potentially long-term health, based on up-to-date data.

• We emphasize that starting HRT closer to menopause has different risk profiles than starting later — and tailor our recommendations accordingly.

• We offer a variety of formulations (oral, transdermal, local) because one size does not fit all; we choose based on symptom profile, risk factors, and patient preference.

• We review therapy regularly — not just at initiation — to reassess continued benefits, risks, and whether the therapy still aligns with patient goals.

Conclusion

The FDA’s move to remove many of the black box warnings on HRT is more than a regulatory shift — it’s a cultural and clinical reset. For too long, fear based on outdated or misinterpreted data has driven decisions, often to the detriment of women’s quality of life.

Now, with more balanced, evidence-based labeling, there’s a clearer path for shared decision-making. For women struggling with menopausal symptoms, this change could mean renewed access, better information, and more confidence in choosing therapy that fits their life and health goals.

If you’re navigating menopause or considering hormone therapy, I encourage you to talk with your clinician — or reach out to us — about what options might be right for you in this new landscape of more informed, personalized care.