black box warning
Medication danger label
A black box warning is the most serious warning required by the U.S.
Food and Drug Administration on prescription drug labeling.
Named for the black border surrounding the text, it alerts physicians and patients to potentially fatal or life-threatening risks: The antidepressant carries a black box warning about increased suicide risk in young adults.
Assigning identifying markers
- package insertMedication's official documentation
- medication guideLeaflet with drug information
- FDA approvalOfficial drug safety certification
- regulatoryInvolving official oversight
drug safety · clinical trials · contraindications · adverse effects · drug interactions · risk management · toxicology · pharmaceuticals
Exposure to harm
- hazardSource of potential harm
- riskPossibility of harm
- alertWarning or watchfulness
- precautionPreventive safety measure
advisory · red flag · severe · life-threatening · fatal · serious · irreversible · mortality
labeling
Assigning identifying markers
- package insertMedication's official documentation
- medication guideLeaflet with drug information
- FDA approvalOfficial drug safety certification
regulatory · drug safety · clinical trials · contraindications · adverse effects · drug interactions · risk management · toxicology · pharmaceuticals
danger
Exposure to harm
precaution · advisory · red flag · severe · life-threatening · fatal · serious · irreversible · mortality · death
- Drug Risksadverse reactions, side effects, drug interactions, overdose, toxicity
- medication labelsdrug name, brand name, generic name, dosage, directions
- pharmacologypharmacology, drugs, pharmacokinetics, dose, drug
- drug lawsuitsdrug recalls, adverse effects, side effects, adverse reactions, drug safety
- Drug Safetydrug safety, adverse reactions, side effects, drug interactions, drug recalls
- FDAdrug approval, approval letter, drug recall, recalls, labeling laws
black box warningFDA approval
Official drug safety certification
safety certification · drug of choice · fast track approval · green light
black, warning, blackout, blacklist, warnings, blackouts, blacklisted, blacklisting