What is a “black box warning”?

A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug.  These warnings are included in the package insert of certain drugs to notify consumers of significant risks of serious or even life-threatening side effects, and they get their name from the black box printed around the warning text. 

Drugs with black box warnings are routinely prescribed.  One study found that within a 30-month period, more than 40% of patients within an ambulatory care setting received at least one medication that carried a black box warning for a serious adverse drug reaction that could potentially affect them.

Unfortunately, some black box warnings are not issued until after a drug harms a large number of patients. If you’ve been harmed by a drug, legal action may be an effective remedy to hold the pharmaceutical company liable for their negligence and help prevent further injuries to other patients. 

Please contact us today for help with your personal injury questions.

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