11/14/2025
So what does this mean?: FDA Removes Black Box Warning on Hormone Replacement Therapy (HRT)
After 20+ years, the FDA has removed the cardiovascular âblack boxâ warning from menopausal hormone therapy. This historic change reflects updated evidence showing HRTâs benefits often outweigh risks for many womenâespecially when started during the menopausal transition. Untreated hormonal deficits arenât benign. Research links estrogen decline to increased cardiovascular risk, cognitive changes, metabolic dysfunction, bone loss, and quality of life impacts.
The key? Personalized medicine. Timing, type, dose, and individual health factors all matter.
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FDA (https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy)
Perspective: Estrogen and the Risk of Cognitive Decline: A Missing Choline(rgic) Link? (2021) (https://pmc.ncbi.nlm.nih.gov/articles/PMC8970832/)Â
Influence of the Onset of Menopause on the Risk of Developing Alzheimerâs Disease (2024) (https://pmc.ncbi.nlm.nih.gov/articles/PMC11387275/)Â
Age of menopause and dementia risk in 10,832 women from the Swedish Twin Registry (2025) (https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70541 #:~:text=2%2C%203,that%20often%20begin%20in%20midlife.)Â
The effect of hormone replacement therapy on cognition and mood (2022) (https://pmc.ncbi.nlm.nih.gov/articles/PMC11497347/)Â
Age of menopause, healthy lifestyle and cardiovascular disease in women: a prospective cohort study (2024) (https://pmc.ncbi.nlm.nih.gov/articles/PMC11874333/ #:~:text=Results,interaction%2C%20p=0.71).)Â
Cardiovascular Disease Risk in Women with Menopause (2025) (https://pmc.ncbi.nlm.nih.gov/articles/PMC12156203/ #:~:text=3.2.&text=Multiple%20meta%2Danalyses%20have%20found,increase%20CVD%20risk%20%5B34%5D)Â
This is for educational purposes only. Discuss HRT with your healthcare provider to determine whatâs right for your unique health profile.