Rethinking Hormone Therapy for Midlife Health: What the Food and Drug Administration’s Label Change Means for Women and Men in Chicago

Published November 2025

For more than two decades, hormone-replacement therapy (HRT) used to treat symptoms of menopause carried one of the most serious warnings in U.S. medicine: the FDA’s “black box” label. That label alerted both patients and physicians to possible life-threatening risks, including cardiovascular disease, stroke, blood clots, breast cancer, and dementia. (Washington Post) 

As of November 2025, the FDA has initiated the removal of these black box warnings for many menopausal HRT products, a decision grounded in updated science, nuanced risk assessment, and the recognition that previous labeling may have created unnecessary fear. (FDA)

For patients and practices focused on preventive, evidence-based, longevity-oriented care, this change invites a new chapter of shared decision-making and clarity.

Why the label existed and why it’s changing

In 2002, the large Women’s Health Initiative (WHI) trial reported that post-menopausal women taking combined estrogen-progestin therapy had increased risks of heart disease, stroke, blood clots, and breast cancer. (JAMA Network) In response, beginning in 2003, the FDA required a black box warning on systemic HRT. The label served as a broad caution, although the original trial population was older (average age 63) and the hormone formulations differed from many in current use. (FDA)

In recent years, clinicians and researchers began to question whether the risk-benefit calculus for HRT remained valid in light of new data and more modern formulations. Recent analyses show that when HRT is initiated within about 10 years of menopause onset or before age 60, the benefits may outweigh the risks — including reductions in mortality, fractures, cardiovascular disease, and cognitive decline. (JAMA Network) 

Based on this evolving evidence, the FDA convened an expert panel in July 2025 and subsequently requested that manufacturers update labeling to remove references to cardiovascular disease, breast cancer, and probable dementia from black box warnings — though some warnings (for example, endometrial cancer with unopposed systemic estrogen) will remain. (Reuters)

As FDA Commissioner Marty Makary stated: the move is about returning to evidence-based communication, rather than one-size-fits-all fear. PBS

What does this mean for midlife care?

As a practice committed to proactive, whole-person health for adults 55+ (and men as well as women), Encore’s lens must frame this regulatory shift thoughtfully:

1. Personalized timing matters
The data suggest that HRT initiated early in the menopausal transition (within 10 years) is more favorable in terms of benefit-risk balance. The former label did not emphasize timing, which contributed to over-generalized caution. JAMA Network 

2. Risk stratification is essential
HRT is not a blanket remedy — individual health history, family history, mode of delivery (oral, patch, vaginal), dose and duration all matter. The new labeling changes reflect that nuance rather than applying the same risk to every usage. JAMA Network 

3. Opportunity for quality of life and longevity
Beyond symptom relief (like hot flashes, night sweats or vaginal dryness), the literature suggests HRT may contribute to improved heart, bone and brain health in select populations — though not every patient will be a candidate. (FDA) 

4. Shared decision-making is more important than ever
Removing the black box label removes one barrier to discussion — but it does not remove the need for thoughtful, patient-centered discussion. At Encore, the conversation becomes richer: What are your symptoms? What matters to you in life and aging? What are your risks and goals?

How Encore supports this shift

We view this change as a signal of the importance of clarity over alarm in midlife care. Here’s how we apply that:

• Extended visits and direct access: We give time for deep conversations about hormones, aging, prevention, and quality of life — not rushed check-ins.
  
  

• Advanced diagnostics and hormone panels: Beyond the standard labs, we assess hormonal balance, metabolic markers, bone/bone-density risk, and brain health indicators.
  
  

• Individualized care roadmaps: Based on your unique profile, lifestyle, and goals, we craft preventive and longevity-focused plans — not generic prescriptions.
  
  

• Continuous partnership: Aging well is a long game; we monitor not just symptoms, but function, resilience, and vitality over time.
  

The label change by the FDA may remove fear-driven barriers — but the core of responsible hormone therapy remains: timing, personalization, monitoring, and ongoing conversation. That aligns directly with Encore’s commitment to elevated, personalize,and preventive care for adults who want to live not just longer, but better.

Conclusion

The removal of black box warnings from many menopausal hormone therapies represents a meaningful regulatory and cultural shift. It opens up opportunities for more nuanced, evidence-based care — but it does not replace thoughtful clinical judgment and individualized planning. At Encore, we believe this moment is an invitation to deepen the quality of midlife care, acknowledge the role hormones play in aging, and walk with patients toward sustained health, clarity, and performance.

If you’re 55 + (or moving into that life stage) and curious about how hormone therapy might fit into your health plan, let’s talk. The conversation has changed — and so can your experience of midlife.

References

• FDA and HHS press release: “HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy” (Nov 10 2025).

• JAMA Viewpoint: Makary et al., “Updated Labeling for Menopausal Hormone Therapy”.

• Reuters article: “US FDA to drop black box warnings from menopause hormone therapies” (Nov 10 2025). Reuters 

• ACOG News Release: “ACOG President Says Label Change on Estrogen Will Increase Access to Hormone Therapy” (Nov 2025). acog.org