Boxed warning
Boxed Warning
A Boxed Warning (pronounced: bɒksd wɔːrnɪŋ), also known as a black box warning or boxed warning, is a type of warning that appears on the package insert for certain prescription drugs, as required by the Food and Drug Administration (FDA).
Etymology
The term "Boxed Warning" comes from the black border that typically surrounds the text of the warning on the package insert. The black border is intended to draw attention to the warning.
Definition
A Boxed Warning is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. It is often added to the labeling of a prescription drug if the drug has been shown, through controlled, clinical studies, to have a significant risk of serious, harmful consequences, including death.
Related Terms
- Adverse effect: An undesired harmful effect resulting from a medication or other intervention such as surgery.
- Clinical trial: A type of research that studies new tests and treatments and evaluates their effects on human health outcomes.
- Package insert: A document included in the package of a medication that provides information about that drug and its use.
- Prescription drug: A pharmaceutical drug that legally requires a medical prescription to be dispensed.
- Food and Drug Administration: A federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
External links
- Medical encyclopedia article on Boxed warning
- Wikipedia's article - Boxed warning
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