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

By: C. Michael White, University of Connecticut, The Conversation

Outlets: The Conversation

Published: November 13, 2025

Words: 1,053

Last Updated: 1 week, 4 days ago


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By C. Michael White, University of Connecticut

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.

But what are these warnings, anyway? What’s their history, …

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