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Menopausal Hormone Update from the FDA

Swor Women's Care Blog Menopausal Hormone Update from the FDA

FDA Hormone Risk-Benefit Reassessment 2026

A long-awaited historic US Department of Health and Human Services (HHS) announcement was made, in November 2025, regarding major updates to past warnings related to the use of menopausal hormone therapies. After more than 20 years of criticism and pleas for a scientific review of the evidence, the FDA has finally recommended removal of multiple risk warnings in dozens of hormone drug products.
 
The scientific evidence supports this decision. There is no basis for serious risk warnings related to cancer, cardiovascular disease and dementia with the typical use of estrogen, progesterone and many related hormone products. Millions of untreated menopausal women have suffered because of fear of unfounded risks. Many doctors and other healthcare providers have declined to provide important hormone replacement because of the risk warnings the FDA now says were unfounded. The FDA also agreed that, although there is some increased risk for blood clots with estrogen pills, there is no increase in risk for patches, creams or other transdermal products.
 
What the large body of scientific evidence does show is that systemic bioidentical HRT is not only safe for most women, but improves overall health and life expectancy. In addition, the risk warnings should never have been applied to low dose, local, topical estrogen which can be a critical treatment in menopausal women for vaginal, bladder and sexual health.
 
Fact Sheet About HRT from the US Dept of Health and Human Services (HHS) 2026
  • Studies have provided evidence that starting HRT within ten years of the onset of menopause can have numerous benefits which for most women outweigh potential risks. Benefits include a reduced risk of all-cause mortality and fractures. HRT has also been associated with 50% reduction in heart attack risk, 64% reduction in cognitive decline, and 35% lower risk of Alzheimer’s.
  • An analysis of 30 trials with 26,708 women participants found HRT was not associated with increased cancer mortality. In fact, women who start HRT before age 60 appear to have a decreased mortality risk.
NEXT.....acceptance and support for bioidentical testosterone,, not just for men, but for women as well.
Author
Dr Swor and his family Swor Women's Care Dr MIchael Swor is the founder and managing OBGYN physician at Swor Women's Care. Posts and blog updates are provided with the help of his partners, Dr Jenny Lichon and Dr KASH, as well as other healthcare providers and staff in the practice.

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