This live EMAS roundtable examined the recent FDA decision to remove Black Box warnings from menopausal hormone therapy (MHT). Bringing together experts from Europe and the United States, the discussion explored the legacy of the Women’s Health Initiative (WHI), the consequences of regulatory messaging, and how menopause care is evolving through evidence, timing, and individualisation.
With Petra Stute,
Angela DeRosa,
Elena Armeni
and Dorenda van Dijken
→ Read the EMAS official statement
What Changed. And Why the Conversation Shifted
While the scientific evidence around menopausal hormone therapy has been available for years, the FDA’s recent decision marked a significant shift in how that evidence is communicated.
As Angela DeRosa explained:
“The science was there all along. It took 23 years for the FDA to correct the way the data were presented.”
She described the decision as a long-overdue acknowledgment of harm caused by fear-driven messaging:
“The Women’s Health Initiative irreparably harmed women’s health for the last two decades. Seventy to ninety million women were denied care they deserved.”
The removal of Black Box warnings from all estrogen therapies, not only vaginal estrogens, was described as a pivotal moment for clinical practice.
The WHI Legacy in Europe
Petra Stute reflected on how the WHI findings initially influenced care across Europe:
“The WHI led to years of uncertainty, undertreatment, and widespread fear among women and healthcare providers.”
Over time, European societies reassessed the data and adjusted guidance accordingly:
“We did not ignore WHI. We learned from it and evolved with the evidence.”
This reassessment laid the groundwork for more balanced, individualised menopause care.
Growing Awareness and Public Conversation
Elena Armeni highlighted that menopause awareness in Europe continued to grow even during periods of uncertainty:
“Societies invested time and effort to create new guidelines once the WHI data started making sense.”
She also pointed to broader cultural changes:
“In countries like the UK, menopause cafés and workplace policies have helped women speak openly and ask for care.”
Menopausal Hormone Therapy Today
The panel strongly agreed that MHT remains one of the most studied and effective treatments in midlife medicine.
Petra Stute summarised the current evidence:
“For healthy women under 60 or within ten years of menopause, the benefits generally outweigh the risks. Timing matters profoundly.”
At the same time, speakers cautioned against replacing fear with overconfidence:
“MHT is a powerful treatment, but it is not a cure for everything. Indication matters.”
Avoiding the Next Extreme
Individualisation was a recurring theme. Elena Armeni emphasised:
“It cannot be one way of treating each and every woman.”
Risk assessment, patient preferences, and regular reassessment remain essential:
“What the patient needs and what the patient wants should drive decisions.”
Education as the Critical Next Step
All speakers agreed that education is now the most urgent priority.
Elena Armeni warned:
“Clinicians cannot reassure patients if they themselves are afraid of hormone therapy.”
Angela DeRosa added:
“We have two decades of clinicians who were never properly taught menopausal medicine.”
Professional societies were seen as central to addressing this gap. As Petra Stute stated:
“Scientific societies must provide calm, clear, and consistent leadership. Our duty is to lead, not react.”
Why This Roundtable Matters
This discussion reflects EMAS’s commitment to evidence-based, balanced, and individualised menopause care. By revisiting the past with honesty and focusing on education and clarity, the roundtable offers clinicians a framework for navigating evolving guidance without repeating previous mistakes.
“We should not replace misinformation with overconfidence. Appropriate care is always balanced care.”
— Petra Stute
Watch the full webinar to hear the complete discussion and expert perspectives shaping the future of menopause care.
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