black box warning

A black box warning is issued by the U.S. Food and Drug Administration (FDA) to inform physicians and patients about any important safety concerns, such as serious side effects or life-threatening risks.In other words it is a type of alert that appears on the pack of certain prescribed drugs.


A black box warning is named for the black border surrounding the text that appears on the package insert, label, and marketing materials that describe the medication.It is the most series type of  warning in prescribed drug labeling which indicates the drug carries a significant risk of series or even life threatening adverse effects.Black box warnings become more prominent in 2004 and got great deal of media attention since then.Currently more than 500 medications in United states carries black box warning.


FDA uses various types of evidence when deciding if a black box warning should be assigned to a medication.The evidence supporting the use of this warning can be obtained directly from randomized-controlled trials during medications approval process.Information received after the medication has already been approved and a particular adverse event is discovered during post marketing reporting can also be used.If new or more frequent adverse event appears after a drug is already on the market,the FDA may also decide to review the data and will then determine if a new boxed warning is  merited.


The FDA's Drug Safety & Risk Management Advisory Committee recently recommended that ADHD stimulant drugs receive a black box warning on their labels to discuss their possible risk of causing high blood pressure, stroke, and sudden death.