What is a black box warning?

A black box warning, also referred to as a boxed warning, is the most urgent warning mandated by the FDA.  It is used to alert consumers of the adverse risks associated with taking certain prescription drugs.  If medical studies show that a drug carries a substantial risk of serious harmful effects, the FDA will require pharmaceutical companies to place this warning on the prescription drugs packaging or its label.

The information on this page is meant to provide a general overview of the law. The laws in your state and/or city may deviate significantly from those described here. If you have specific questions related to your situation you should speak with a local attorney.

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