“In November 2025, the US Food and Drug Administration (FDA) announced its intention to remove most box warnings from the package inserts of approved estrogen and hormone replacement therapy (HRT) products.”
“We are the 9 living former members of the Women’s Health Initiative (WHI) data and safety monitoring board.”
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“Although we support a reassessment of box warnings for estrogen products, we are concerned about the process the FDA used to make its recommendations and worried that many women will not be aware that some of the products may lead to adverse clinical outcomes.”
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J. Wittes, et al
Menopausal Hormone Labels Should Rely on Evidence, Not Opinion
Journal Of The American Medical Association —– volume 335 #14 — April 14, 2026 — page 1201