Boxed warning
In the United States, a boxed warning (sometimes black box warning, colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called becausethe U.S. Food and drug Administration specifies that it is formatted with a 'box' or border around the text. The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.
[[Category:Drugs
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