11/11/2025
A BIG WIN FOR WOMEN’S HEALTH!!
Monday, Nov 10, the FDA released a statement removing misleading FDA warnings on Hormone Replacement Therapy.
https://www.hhs.gov/press-room/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy.html
Key statements:
1 After more than two decades of fear and misinformation surrounding hormone replacement therapy (HRT), the U.S. Food and Drug Administration (FDA) is initiating the removal of broad “black box” warnings from HRT products for menopause following a comprehensive review of the scientific literature.
2 Language in product labeling will be updated to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.
3 For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT.
4 FDA is returning to evidence-based medicine and giving women control over their health again.
5 Estrogen is a key hormone for women’s health. Every single part of a woman’s body depends on estrogen to operate at its best—including the brain, bones, heart, and muscles.
6 Many more women can reduce their risk of fracture, heart disease, and immune and cognitive decline while extending their vigor.
7 Randomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures.
8 Women may also reduce their risk of cardiovascular diseases by as much as50% (https://pubmed.ncbi.nlm.nih.gov/2005736/) (https://pubmed.ncbi.nlm.nih.gov/2005736/), Alzheimer’s disease by35% (https://pubmed.ncbi.nlm.nih.gov/8885820/) (https://pubmed.ncbi.nlm.nih.gov/2005736/), (https://pubmed.ncbi.nlm.nih.gov/8885820/) and bone fractures by 50 to 60% (https://www.nejm.org/doi/full/10.1056/NEJM198011203032102) (https://www.nejm.org/doi/full/10.1056/NEJM198011203032102).
