FDA lifts warnings on hormone therapy to treat menopause
By: Laura Trujilio
USA Today
..... For the past decade, Dr. Heather Hirsch has tired to convince women that hormone therapy drugs are the best way to treat symptoms of menopause and menopause. But warning labels on estrogen have scared many women away from getting the care they need.
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Now the Food and Drug Administration is asking drug companies to remove these labels, known as black box warnings, on hormone therapy drugs containing estrogen. The change will be monumental in helping more women manage disruptive menopause and perimenopause symptoms ranging from increased urinary tract infections to night sweats.
..... The black box warning is the highest safety label that the FDA can put on prescriptions. Since 2003, the black box warning has appeared on all hormone therapy including estrogen - pills, crams, sprays and patches.
..... A black box warning doesn't mean a drug isn't safe. It does mean it carries increased risks.
..... "The label was outdated and harmful," said Hirsch, a physician and founder of the Menopause Clinic at Brigham and Woman's Hospital in Boston who testified in front of the FDA to remove the labels. "It led to so many women not getting the care they need."
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A 2002 women's Health Initiative study linked hormone therapy to slightly higher risks of beast cancer, heart attack and strokes in postmenopausal woman. The risk, recognized later, were mostly found in women who were older when they started hormone therapy.
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Use of hormone therapy dropped from about 40% in 1999 to about 5% in 2020, according to the Journal of the American Medical Association.
..... This led to women unnecessarily experiencing symptoms such a shot flashes and brain fog, Hirsch says.
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Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary made the announcement November 10. [2025]
..... "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,: Makary said. "For too long, issues of women's helaht have been under-recognized. Women and their physicians should make decisions based on data, not fear."
..... The administration recommends that hormone therapy start within 10 years of menopause onset or before age 60.