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In the United States, a black box warning (also sometimes called a black label warning or boxed warning ^[1]) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.

A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it.

A black box warning is the sternest warning by the U.S. Food and Drug Administration (FDA) that a medication can carry and still remain on the market in the United States.

A black box warning appears on the label of a prescription medication to alert you and your healthcare provider about any important safety concerns, such as serious side effects or life-threatening risks.

BOXED WARNING (§ 201.57(c)(1))

• There is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that is essential that it be considered in assessing the risks and benefits of using the drug.

• There is a serious adverse reaction that can be prevented or reduced in frequency or severity by appropriate use of the drug (e.g., patient selection, careful monitoring, avoiding certain concomitant therapy, addition of another drug or managing patients in a specific manner, avoiding use in a specific clinical situation)

• FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted (e.g.,  under 21 CFR 314.520 and 601.42 “Approval with restrictions to assure safe use” or under 505-1 (f)(3) of the Federal Food, Drug, and Cosmetic Act (FDCA) “Risk Evaluation and Mitigation Strategies” Elements to assure safe use). ^[1]

 

Disclaimer: The health and medical information on our Web site is not intended to take the place of advice or treatment from healthcare professionals. It is also not intended to substitute for the users’ relationships with their own health care/pharmaceutical providers.