At Wellness Labs, we offer advanced hormone panels designed to support clinicians and patients in making informed decisions around hormone replacement therapy. Whether you are initiating HRT or optimizing an existing regimen, our hormone testing gives you the data you need for targeted, safe, and effective care.
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My PortalOn November 10, 2025, the U.S. Department of Health and Human Services (HHS) together with the FDA announced a landmark change: the removal of broad “black box” warnings from many menopausal hormone replacement therapy (HRT) products. These warnings—originally applied following the Women’s Health Initiative (WHI) trials in the early 2000s—had cited increased risks of breast cancer, cardiovascular disease, stroke and dementia.
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The Wellness Labs Blog. Your go-to resource for expert insights on health, wellness, and diagnostic testing. Explore informative articles on preventive care, lab testing, and personalized health solutions. Stay informed and take control of your well-being with trusted advice.Blog
The Wellness Labs Blog. Your go-to resource for expert insights on health, wellness, and diagnostic testing. Explore informative articles on preventive care, lab testing, and personalized health solutions. Stay informed and take control of your well-being with trusted advice.https://www.tiktok.com/@wellness.labs?is_from_webapp=1&sender_device=pcHHS & FDA Move to Remove “Black Box” Warnings on Menopausal Hormone Therapy — What Women and Providers Should Know
- Greater confidence in considering HRT for symptom relief (hot flushes, night sweats, bone health, mood) when initiated early post‑menopause. Health and Human Services - A need for individualized hormone testing and monitoring to assess baseline hormone status and track response. - Ongoing consultation with a hormone‑knowledgeable clinician, given that HRT is not without risks and requires tailored decision‑making.
What this means for patients and providers:
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According to the FDA’s fact sheet, recent review of the literature shows that when systemic HRT is initiated within 10 years of menopause or before age 60, many of the previously feared risks are not evident and the benefit‑risk balance is markedly different. Importantly, the label change does not eliminate all risks: for women with a uterus using unopposed estrogen (without progesterone) the risk of endometrial (uterine) cancer remains, and those labels will retain warnings. For diagnostic laboratories and providers like Wellness Labs, this regulatory shift clarifies the urgency and importance of personalized hormone assessment. Effective HRT requires knowledge of individual hormone levels, timing of initiation, and regimen tailoring—areas we specialize in.
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