what is black box warning information
A black box warning, also known as a âblack label warningâ or âboxed warning,â is named for the black border surrounding the text of the warning that appears on the package insert, label, and other literature describing the medication (for example, magazine advertising). 1  This warning is the most serious medication warning required by the FDA. When the FDA Requires One. The FDA requires a black box warning for one of the following situations: 1  The medication can cause serious undesirable effects (such as a fatal, life-threatening or permanently disabling adverse reaction) compared with the potential benefit from the drug.