Boxed Warning

A boxed warning is a prominent warning in prescription drug labeling that calls attention to serious or life-threatening risks. It is sometimes called a black box warning. The warning describes known risk information and may identify circumstances in which a drug should be avoided or closely monitored. A boxed warning does not resolve every legal question. A product case may still examine what the manufacturer knew, when it knew it, and whether the warning adequately communicated the relevant risk.