Are hormones safe? The FDA removes Black Box Warning on HRT
The FDA is removing the black box warning from hormone replacement therapy because new research shows the original risks were overstated or just wrong. This error is most likely what is responsible for leading to millions of men and women being denied a beneficial treatment.
The updated guidance emphasizes that for most, starting HRT within 10 years of menopause (or before age 60) offers greater benefits like reduced fractures, heart disease, and cognitive decline risks thereby outweighing the potential harms. This change empowers personalized care! It is also recognizing HRT's significant potential to improve quality of life, solid bone health, as well as long-term health outcomes for many women and men.
Why the Change?
The original science has evolved - aka someone decided to read the study and use critical thinking skills. The initial black box warning stemmed from early findings in the Women's Health Initiative (WHI) study in the early 2000s, which showed increased risks of breast cancer, blood clots, heart attack, and stroke. These side effects were primarily in older women starting HRT decades after menopause.
However, decades of follow-up and new research, including data from women starting closer to menopause, revealed that these risks are significantly lower and often reversed when HRT is initiated within 10 years of menopause or before age 60. The FDA's decision reflects this better understanding of patient improvement across many health categories while also acknowledging that the original warning created a misleading perception of danger for many appropriate candidates.
Benefits: A New Era of Personalized Health from your Naturopathic Physician
The update allows for more precise, individualized treatment. It also recognizes HRT's profound benefits when used appropriately. The many possible benefits are (but not limited to): reducing hot flashes, improving sleep, and significantly lowering risks of osteoporosis, heart attacks (by up to 50%), cognitive decline, and Alzheimer's (by 35%).
It removes a major barrier for patients who care about their health and the quality of their life. It is encouraging doctors and patients to have informed conversations about tailoring HRT, particularly for younger, healthier women, to manage menopause symptoms and potentially extend vibrant, healthy living.
What It Means for You
While the warning is gone for many products, it doesn't mean HRT is risk-free for everyone; the risk of endometrial cancer with unopposed estrogen remains. So it’s important that your naturopath have hormone training and experience with it.
The crucial takeaway is that timing and individual health matter, necessitating an open discussion with your healthcare provider to weigh the benefits against your personal risks and determine if HRT is right for you, supporting a more proactive approach to women's long-term health.
Schedule a free 15-minute appointment today with Dr. Cordova to discuss the potential of working with me via Telemedicine/Telehealth.
Dr. Evelyn Cordova | Telemedicine Naturopath