SafetyGlossary Term
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
A black box warning, also known as a boxed warning, represents the most serious type of safety alert that the U.S. Food and Drug Administration can require for prescription drug labeling. The name derives from the distinctive black border that surrounds the warning text, drawing immediate attention to critical safety information. These warnings are reserved for risks that are serious enough to warrant special emphasis and typically involve risks of death or severe, potentially irreversible adverse effects that may affect prescribing decisions or require special monitoring.
The FDA may require a black box warning when evidence demonstrates a serious risk that prescribers should be aware of when making treatment decisions. This evidence may emerge during clinical development, leading to the warning being included in the initial approved labeling, or may surface during post-marketing surveillance, necessitating labeling updates for products already on the market. In either case, the warning must describe the nature and magnitude of the risk, the affected population, and any recommended monitoring or precautions.
While black box warnings are specific to FDA-regulated products in the United States, similar concepts exist in other regulatory jurisdictions. The European Medicines Agency may require prominent safety warnings, and products may carry restrictions on their use through risk evaluation and mitigation strategies. For clinical trials conducted under FDA jurisdiction, the presence of black box warnings on comparator drugs or the anticipation of such warnings for investigational products influences protocol design, informed consent content, and safety monitoring requirements throughout development.
Informed consent disclosure
"The informed consent form explicitly described the black box warning on the comparator drug regarding increased cardiovascular mortality risk, ensuring participants understood this serious safety concern before enrollment."
Post-marketing requirement
"Based on post-marketing reports of fatal hepatotoxicity, the FDA required the manufacturer to add a black box warning and implement a restricted distribution program with mandatory liver function monitoring."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
A specific situation or condition in which a drug, procedure, or treatment should not be used because it may be harmful to the patient.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
A black box warning, also known as a boxed warning, represents the most serious type of safety alert that the U.S. Food and Drug Administration can require for prescription drug labeling. The name derives from the distinctive black border that surrounds the warning text, drawing immediate attention to critical safety information. These warnings are reserved for risks that are serious enough to warrant special emphasis and typically involve risks of death or severe, potentially irreversible adverse effects that may affect prescribing decisions or require special monitoring.
The FDA may require a black box warning when evidence demonstrates a serious risk that prescribers should be aware of when making treatment decisions. This evidence may emerge during clinical development, leading to the warning being included in the initial approved labeling, or may surface during post-marketing surveillance, necessitating labeling updates for products already on the market. In either case, the warning must describe the nature and magnitude of the risk, the affected population, and any recommended monitoring or precautions.
While black box warnings are specific to FDA-regulated products in the United States, similar concepts exist in other regulatory jurisdictions. The European Medicines Agency may require prominent safety warnings, and products may carry restrictions on their use through risk evaluation and mitigation strategies. For clinical trials conducted under FDA jurisdiction, the presence of black box warnings on comparator drugs or the anticipation of such warnings for investigational products influences protocol design, informed consent content, and safety monitoring requirements throughout development.
Informed consent disclosure
"The informed consent form explicitly described the black box warning on the comparator drug regarding increased cardiovascular mortality risk, ensuring participants understood this serious safety concern before enrollment."
Post-marketing requirement
"Based on post-marketing reports of fatal hepatotoxicity, the FDA required the manufacturer to add a black box warning and implement a restricted distribution program with mandatory liver function monitoring."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
A specific situation or condition in which a drug, procedure, or treatment should not be used because it may be harmful to the patient.