In the United States, a black box warning, or black label warning, is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse side effects.

The black box warning is the most severe warning United States Food and Drug Administration can issue. Named for the black borer that commonly surrounds its text, a black box warning means that medical studies indicate that the accompanying drug carries serious or life-threatening risks. The FDA can require a pharmaceutical company to carry the black box warning on the labeling of a drug.

The most black box warning issued by the FDA pertains to gadolinium-based MRI contrast agents. Agents containing gadolinium have been liked to the development of nephrogenic systemic fibrosis (NSF) a potentially fatal skin disorder. The FDA issued a black box warning on all gadolinium-based contrast agents on September 9, 2010.

If you have developed NSF because of gadolinium-based MRI contrast agents, you may be eligible for compensation. Please contact a gadolinium attorney of Williams Kherkher by calling 800-761-3187.