Black box warnings: What do they mean to pharmacists and patients

Consultant Pharmacist

Volumn 27, Issue 7, 2012, Pages 482-492

  Martin, Caren McHenry ^a   Borgelt, Laura ^b  

^a University of Colorado ^*

^b UNIVERSITY OF COLORADO   (United States)

Author keywords

Adverse drug event; Black box warning; Drug safety; Medication

Indexed keywords

AMINOGLYCOSIDE; AMIODARONE; ANTIANEMIC AGENT; ANTIDEPRESSANT AGENT; ATYPICAL ANTIPSYCHOTIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CARBAMAZEPINE; CILOSTAZOL; CLOPIDOGREL; CLOZAPINE; DISOPYRAMIDE; DRONEDARONE; ESTROGEN DERIVATIVE; ETANERCEPT; KETOCONAZOLE; LAMOTRIGINE; LONG ACTING BETA AGONIST; LOOP DIURETIC AGENT; LOW MOLECULAR WEIGHT HEPARIN; METFORMIN; METHADONE; METHOTREXATE; METHYLPHENIDATE; METRONIDAZOLE; MIDODRINE; MODAFINIL; PARACETAMOL; QUINOLONE DERIVATIVE; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ABSENCE OF SIDE EFFECTS; AGRANULOCYTOSIS; ARTICLE; BLACK BOX WARNING; BLOOD DYSCRASIA; BONE MARROW SUPPRESSION; BONE NECROSIS; CARDIOVASCULAR DISEASE; CEREBROVASCULAR DISEASE; CLINICAL EVALUATION; CLINICAL PROTOCOL; DEMENTIA; DRUG APPROVAL; DRUG DEPENDENCE; DRUG EFFICACY; DRUG FATALITY; DRUG LABELING; DRUG MANUFACTURE; DRUG PACKAGING; DRUG SAFETY; DRUG WITHDRAWAL; ELECTROLYTE DISTURBANCE; ENDOMETRIUM CARCINOMA; FOOD AND DRUG ADMINISTRATION; GENERAL PRACTITIONER; HEART ATRIUM FIBRILLATION; HEART FAILURE; HEMATOMA; HUMAN; HYPOTENSION; INFECTION; LACTIC ACIDOSIS; LIVER DYSFUNCTION; LIVER TOXICITY; LUNG TOXICITY; LYMPHOMA; MEDICINE; MEDICOLEGAL ASPECT; MENTAL DISEASE; MUSCLE WEAKNESS; MYASTHENIA GRAVIS; NEOPLASM; NEPHROTOXICITY; NERVE PARALYSIS; NEUROTOXICITY; NONHUMAN; ORTHOSTATIC HYPOTENSION; PATIENT CARE; PATIENT SELECTION; PHARMACIST; PNEUMONIA; QT PROLONGATION; RESPIRATION DEPRESSION; RISK ASSESSMENT; SEIZURE; SKIN MANIFESTATION; STEVENS JOHNSON SYNDROME; SUICIDE ATTEMPT; TACHYCARDIA; TENDON INFLAMMATION; TENDON RUPTURE; TUBERCULOSIS; TUMOR LYSIS SYNDROME;

DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG LABELING; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACISTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84863921854     PISSN: 08885109     EISSN: None     Source Type: Journal    
DOI: 10.4140/TCP.n.2012.482     Document Type: Article

References (8)

1. Food and Drug Administration. Guidance for industry. Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products - content and format. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm075096.pdf. Accessed February 20, 2012.
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8. Federal Register March 27, 2008;73. Available at http://www.gpo.gov/ fdsys/pkg/FR-2008-03-27/pdf/E8-6201.pdf. Accessed December 20, 2011.