Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network

C. Ferrajolo, P. M. Coloma, K. M. Verhamme, M. J. Schuemie, S. de Bie, R. Gini, R. Herings, G. Mazzaglia, G. Picelli, C. Giaquinto, L. Scotti, P. Avillach, L. Pedersen, F. Rossi, A. Capuano, J. van der Lei, G. Trifiro, M. C. Sturkenboom, Eu-Adr consortium

Research output: Contribution to journalArticleAcademicpeer-review


BACKGROUND: Data mining in spontaneous reporting databases has shown that drug-induced liver injury is infrequently reported in children. OBJECTIVES: Our objectives were to (i) identify drugs potentially associated with acute liver injury (ALI) in children and adolescents using electronic healthcare record (EHR) data; and (ii) to evaluate the significance and novelty of these associations. METHODS: We identified potential cases of ALI during exposure to any prescribed/dispensed drug for individuals 1 and in the presence of at least three exposed cases of ALI. Potentially new signals were distinguished from already known associations concerning ALI (whether in adults and/or in the paediatric population) through manual review of published literature and drug product labels. RESULTS: The study population comprised 4,838,146 individuals aged
Original languageEnglish
Pages (from-to)99-108
Number of pages10
JournalDrug Safety
Issue number2
Publication statusPublished - 2014


  • Adolescent *Adverse Drug Reaction Reporting Systems/organization & administration/statistics & numerical data Chemical and Drug Induced Liver Injury/*epidemiology/etiology Child Child Welfare Child, Preschool *Data Mining Databases, Factual Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology Electronic Health Records European Union Humans Infant Infant, Newborn International Cooperation Liver Failure, Acute/*epidemiology/etiology

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