SafetyGlossary Term
A specific situation or condition in which a drug, procedure, or treatment should not be used because it may be harmful to the patient.
Contraindications identify circumstances under which use of a therapeutic intervention poses unacceptable risks that outweigh potential benefits, serving as critical safety information that guides both clinical trial eligibility and clinical practice decisions. In drug development, contraindications emerge from preclinical studies, clinical trial experience, and post-marketing surveillance, evolving as the evidence base grows. They represent absolute or relative prohibitions that must be clearly communicated to prescribers and patients.
Absolute contraindications describe situations where the intervention should never be used because the risk of harm is prohibitively high. These typically reflect known severe reactions, such as anaphylaxis to the drug or a component, or documented serious outcomes in specific populations, such as teratogenic effects precluding use during pregnancy. Relative contraindications indicate situations where increased risk exists but where the intervention may be used with appropriate precautions, enhanced monitoring, or when benefits clearly justify the risks.
In clinical trials, contraindications inform the exclusion criteria that determine participant eligibility. Investigators must verify the absence of contraindicated conditions during screening and remain vigilant for the development of contraindicated conditions during the trial. If a participant develops a contraindicated condition while enrolled, protocol discontinuation provisions typically require withdrawal from the investigational product. The comprehensive identification and characterization of contraindications during development is essential for informing product labeling that will guide safe use after marketing approval.
Eligibility screening
"The investigator determined that the prospective participant was ineligible because their history of severe hepatic impairment represented a contraindication to the investigational product, which was known to be extensively metabolized by the liver."
Protocol discontinuation
"When the participant became pregnant during the trial, she was immediately discontinued from the study drug because pregnancy was an absolute contraindication due to the teratogenic potential identified in preclinical studies."
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 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.
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.
Contraindications identify circumstances under which use of a therapeutic intervention poses unacceptable risks that outweigh potential benefits, serving as critical safety information that guides both clinical trial eligibility and clinical practice decisions. In drug development, contraindications emerge from preclinical studies, clinical trial experience, and post-marketing surveillance, evolving as the evidence base grows. They represent absolute or relative prohibitions that must be clearly communicated to prescribers and patients.
Absolute contraindications describe situations where the intervention should never be used because the risk of harm is prohibitively high. These typically reflect known severe reactions, such as anaphylaxis to the drug or a component, or documented serious outcomes in specific populations, such as teratogenic effects precluding use during pregnancy. Relative contraindications indicate situations where increased risk exists but where the intervention may be used with appropriate precautions, enhanced monitoring, or when benefits clearly justify the risks.
In clinical trials, contraindications inform the exclusion criteria that determine participant eligibility. Investigators must verify the absence of contraindicated conditions during screening and remain vigilant for the development of contraindicated conditions during the trial. If a participant develops a contraindicated condition while enrolled, protocol discontinuation provisions typically require withdrawal from the investigational product. The comprehensive identification and characterization of contraindications during development is essential for informing product labeling that will guide safe use after marketing approval.
Eligibility screening
"The investigator determined that the prospective participant was ineligible because their history of severe hepatic impairment represented a contraindication to the investigational product, which was known to be extensively metabolized by the liver."
Protocol discontinuation
"When the participant became pregnant during the trial, she was immediately discontinued from the study drug because pregnancy was an absolute contraindication due to the teratogenic potential identified in preclinical studies."
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 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.
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.