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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.

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This article is intended to be helpful and informative. But even common legal matters can become complex and stressful. A qualified harmful drugs lawyer can address your particular legal needs, explain the law, and represent you in court. Take the first step now and contact a local harmful drugs attorney to discuss your specific legal situation.

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