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The Conversation
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C. Michael White, Distinguished Professor of Pharmacy Practice, University of Connecticut

What’s a ‘black box’ warning? A pharmacologist explains how these labels protect patients

FDA
Black box warnings can influence whether or not clinicians decide to prescribe a drug. SDI Productions/E+ via Getty Images

A “black box” warning on a health product sounds pretty scary – maybe even more so when it’s suddenly being taken off the packaging.

Americans were reminded of this type of public health messaging on Nov. 10, 2025, when the Food and Drug Administration announced it is removing the “black box” warning from hormone replacement therapy for menopause.

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