FDA To Remove Black Box Warning for HRT. Advancing Women’s Health.

Recently, the FDA announced plans to remove black box warnings from HRT replacement therapy for women: estrogen/progestin. This black box label has been in place since 2003 after a research study published by the Women’s Health Initiative (WHI)  indicated increased risk for breast cancer, cardiovascular events and stroke among women receiving combined HRT. 

However, the WHI study faced significant critique. Researchers and clinicians have identified several flaws and limitations, those of which included: age of participants, timing of therapy initiation, types and routes of hormone formulations used and baseline health status.Despite these limitations, the WHI findings became the foundation for decades of restrictive guidance on hormone therapy. These variables are critical to consider before generalizing outcomes to all women.

It’s also important to remember that hormone replacement therapy extends beyond symptom management. Estrogen acts as a powerful neurosteroid, supporting brain health and cognitive function (women are nearly twice as likely as men to develop Alzheimer’s disease). It also helps preserve bone density, which declines sharply after menopause, and protects cardiovascular health by maintaining vascular flexibility and lipid balance.

Functional practitioners have long understood the benefits of HRT replacement for women beyond just managing hot flashes but to preserve heart bone health to enhance longevity. 

It is both refreshing and exciting to see that reflection in the broader healthcare landscape. I am looking forward to publications in the future that support the health benefits HRT replacement for women that we have known.