Signal Detection of Potentially Drug-Induced Acute Liver Injury in Children Using a Multi-Country Healthcare Database Network

• Published in: Drug safety 2014-02, Vol.37 (2), p.99-108
• Main Authors: Ferrajolo, Carmen, Coloma, Preciosa M., Verhamme, Katia M. C., Schuemie, Martijn J., de Bie, Sandra, Gini, Rosa, Herings, Ron, Mazzaglia, Giampiero, Picelli, Gino, Giaquinto, Carlo, Scotti, Lorenza, Avillach, Paul, Pedersen, Lars, Rossi, Francesco, Capuano, Annalisa, van der Lei, Johan, Trifiró, Gianluca, Sturkenboom, Miriam C. J. M.
• Format: Article
• Language: English
• Subjects: Analgesics; Biological and medical sciences; Classification; Clinical trial. Drug monitoring; Codes; Disease; Drug Safety and Pharmacovigilance; General pharmacology; Health care policy; Hospitals; Laboratories; Medical sciences; Medicine; Medicine & Public Health; Original Research Article; Pharmacology. Drug treatments; Pharmacology/Toxicology; Population; Primary care; Product safety; Statistical methods; Studies; Teenagers
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-013-0132-9

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