Black box warning
Type of warning that appears on the package insert for certain prescription drugs
In the United States, a boxed warning is a warning that death or serious injury may result from the use of a particular drug. It appears near the beginning of the package insert for certain prescription drugs and biologics, so called because the U.S. Food and Drug Administration specifies that it be concise and be formatted with a "box" or border around the text and a heading in all caps, containing "WARNING", to emphasize its importance. The FDA can require a pharmaceutical company to place a boxed warning. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects.
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This entry incorporates text from “Black box warning” on English Wikipedia. Contributors are listed in the page history. Text is available under the Creative Commons Attribution-ShareAlike 4.0 License. Selected authority identifiers and statements are retrieved from Wikidata under CC0; their references and qualifiers remain part of the verification path.