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Black Box Warning

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Updated August 28, 2008

Definition: A black box warning appears on the label of a prescription medication to alert consumers and healthcare providers about safety concerns, such as serious side effects or life-threatening risks. A black box warning is the most serious medication warning required by the U.S. Food and Drug Administration (FDA).
Also Known As: black label warning, boxed warning
Examples:
The FDA requires a black box warning on all antidepressants because of an increased risk of suicidal thinking and behavior in young adults ages 18 to 24 during initial treatment - generally the first one to two months of therapy.

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