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.

Search LawInfo's Harmful Drugs Resources

Lead Counsel Rated Law Firm

Click Here to Learn More