FDA removes black box warnings on hormone therapy—what this means for you
For those of you who want the snapshot – this statement says it ALL….
“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” said FDA Commissioner Makary. He continues to state that “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”
This information is not new to Dr. Andrea who specializes in BHRT and has diligently fought to educate the truth about hormones to every patient she encounters. She avidly and routinely studies the old and new literature on this topic and has done so for over a decade. Her prescribing is based on a proper understanding of the literature and she has been promoting a clear definition of the historical literature for many years now. This change made public by the FDA is very gratifying!!! You see, this is NOT new information….rather this is simply a CORRECTED statement of what we have always known…..hormones are valuable and effective tools in the treatment of both men and women. No longer should women be denied the tremendous benefit that comes forth from a tool that has been INCORRECTLY shamed and vilified. It is about time that the historical data and literature is being clarified for both conventional and nonconventional practitioners on such a grand scale. If you have been unclear or have friends who are fearful of hormones, please provide them with this email.
Read on for more information or if you want further details.
The FDA has officially initiated the removal of long-standing “black box” warnings from menopausal hormone therapy products, marking a significant shift in how these treatments are understood and communicated. This update corrects decades of confusion and fear that stemmed from an older study and brings the guidance in line with current, evidence-based research. At Wellspring Clinic, we want to ensure our patients understand what has changed, why it matters, and how this may positively impact your care moving forward.
Why this matters
The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature, an expert panel in July, and a public comment period. The agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.
“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Secretary Kennedy. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”
Thank you for trusting us with your care and that of your family and friends! If you’d like to schedule an appointment or ask questions, please call our office at 480-946-9222.
The Wellspring Clinic Team
- Published in Email Communication




