Black Box Warnings

The prominent warning labels (generally printed inside black boxes) on packages for certain prescription medications in the United States. These warnings typically arise from post-market surveillance or post-approval clinical trials that bring to light serious adverse reactions. The U.S. Food and Drug Administration (FDA) subsequently may require a pharmaceutical company to place a black box warning on the labeling or packaging of the drug. Although medications with black box warnings often enjoy widespread use and, with cautious use, typically do not result in harm, these warnings remain important sources of safety information for patients and health care providers. They also emphasize the importance of continued, post-market surveillance for adverse drug reactions for all medications, especially relatively new ones.

Black Box Warnings Resources
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