Politico Prescription Plus: FDA Removes Black Box HRT Warning

Politico, November 11, 2025: FDA Commissioner Marty Makary announces that FDA seeks eliminating most black box warnings from hormone therapy for menopause and accuses “dogma” that scared women. NCHR Diana Zuckerman said risks of cancer and heart disease are well established and claims of incomparable benefits are PR rather than science.

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F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause

The New York Times, November 10, 2025: This NYT article describes the different data and opinions regarding FDA Commissioner Makary’s decision to remove the black box from all hormone therapy products for menopause despite risks of cancer and stroke. NCHR president Dr. Diana Zuckerman explains why this is a step backward for women’s health.

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FDA ‘serious’ about hormone therapy changes

Politico, October 28, 2025: Politico predicts FDA will revise black box warnings on hormones for menopause, but it isn’t clear how. NCHR’s Diana Zuckerman explains warnings are needed but require more nuance because the evidence is different for hormone creams compared to pills, and evidence of risks and benefits for pills depend on factors such as the type of hormones and the age, medical history, and other differences in the women.

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