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FDA Removes Boxed Warnings from Six Menopausal Hormone Therapies

Feb 13, 2026

The FDA removed black box warnings related to breast cancer, cardiovascular disease and dementia from six hormone replacement therapies for menopausal women, following a comprehensive review of scientific literature.

FDA Removes Black Box Warning from Menopausal Hormone Therapy Products

Feb 13, 2026

The FDA has approved labeling changes to six menopausal hormone therapy products, removing boxed warnings related to cardiovascular disease, breast cancer, and probable dementia that had been in place since 2003.