FDA lifts black box warnings: A new era for hormone replacement therapy

The Food and Drug Administration (FDA) has removed black box warnings from most hormone replacement therapy (HRT) products used to treat symptoms of menopause. Recent clinical trials and long-term studies show that early initiation of HRT significantly improves health outcomes and reduces risks of heart disease and dementia.

In 2003, the FDA added black box warnings to HRT products because the Women’s Health Initiative (WHI) study showed increased risks of breast cancer, cardiovascular disease and dementia. However, WHI had limitations: participants averaged 63 years old (well beyond typical menopause onset); older hormone formulations were used and timing of therapy initiation wasn't considered. Those with high levels of education and white women were overrepresented in the WHI study. These factors led to decades of caution and underutilization of HRT.

Scientific evidence

• Reanalysis of WHI data shows no elevated risk of breast cancer or cardiovascular disease in women who started HRT before age 60 or within 10 years of menopause
• The KEEPS trial found no increase in cardiovascular risk and showed improvements in mood, bone density and vascular health
• A Case Western Reserve study analyzed 120 million patient records: 60% lower odds of breast cancer, stroke and heart attack in women starting estrogen therapy during perimenopause
• An FDA expert panel concluded timing, formulation and dosage are critical and supported removal of warnings
• Benefits included: 50% reduction in heart attack risk, 64% reduction in cognitive decline, 35% lower risk of Alzheimer’s disease and no significant increase in breast cancer risk when HRT is started early

Employer implications

• Update health benefits to cover HRT options and newer FDA-approved treatments
• Enhance menopause support programs, including telehealth and educational resources
• Promote health literacy through webinars and myth-busting sessions
• Review leave and accommodation policies for menopause-related symptoms
• Ensure inclusion, belonging and diversity by supporting transgender and nonbinary employees who may require HRT
• Monitor legal and regulatory updates for compliance with EEOC and ADA standards

Employee implications

• Talk to your doctor again: What’s the right treatment plan for you based on your age, familial risks and where you're in your journey (Peri/Meno/Post Menopause)
• Understand the updated risk profile: Hormone Replacement Therapy (HRT) still carries some risk; revisit symptoms and potential treatment options tailored to you
• Advocate for yourself: Informed decision fosters empowerment and improves provider accountability
• Stay informed and educated: As new guidelines, women’s benefits and providers are introduced to the healthcare market, stay up-to-date and evaluate the best options for you

Strategic recommendations

• Position your organization as a leader in women’s health
• Improve retention and satisfaction among mid-career women through enhanced benefits for women’s health
• Align with a holistic women’s health strategy and productivity goals by addressing menopause proactively

Authors

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Elaine-Marie Cannella, RN, BSN, MSN, FCNS

Senior Director, Health, Equity and Wellbeing

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Mary Kay Lopez RN, MA

Senior Director, Health Equity and Wellbeing Strategy Leader

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