{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T17:21:36Z","timestamp":1779211296081,"version":"3.51.4"},"reference-count":43,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2013,4,17]],"date-time":"2013-04-17T00:00:00Z","timestamp":1366156800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2013,10]]},"DOI":"10.1007\/s40264-013-0045-7","type":"journal-article","created":{"date-parts":[[2013,4,16]],"date-time":"2013-04-16T11:17:27Z","timestamp":1366111047000},"page":"1007-1016","source":"Crossref","is-referenced-by-count":16,"title":["Idiopathic Acute Liver Injury in Paediatric Outpatients: Incidence and Signal Detection in Two European Countries"],"prefix":"10.1007","volume":"36","author":[{"given":"Carmen","family":"Ferrajolo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katia M. C.","family":"Verhamme","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gianluca","family":"Trifir\u00f2","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geert W.","family":"\u2018t Jong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlo","family":"Giaquinto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gino","family":"Picelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alessandro","family":"Oteri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"de Bie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vera E.","family":"Valkhoff","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martijn J.","family":"Schuemie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giampiero","family":"Mazzaglia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudio","family":"Cricelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Rossi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annalisa","family":"Capuano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam C. J. M.","family":"Sturkenboom","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2013,4,17]]},"reference":[{"key":"45_CR1","doi-asserted-by":"crossref","unstructured":"Narkewicz MR, Dell Olio D, Karpen SJ, et al. Pattern of diagnostic evaluation for the causes of pediatric acute liver failure: an opportunity for quality improvement. J Pediatr. 2009;155:801\u20136.e1.","DOI":"10.1016\/j.jpeds.2009.06.005"},{"key":"45_CR2","doi-asserted-by":"crossref","first-page":"730","DOI":"10.1002\/hep.23696","volume":"52","author":"RJ Fontana","year":"2010","unstructured":"Fontana RJ, Seeff LB, Andrade RJ, et al. Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop. Hepatology (Baltimore). 2010;52:730\u201342.","journal-title":"Hepatology (Baltimore)"},{"key":"45_CR3","doi-asserted-by":"crossref","first-page":"1187","DOI":"10.1111\/j.1365-2036.2006.03117.x","volume":"24","author":"MB Valle De","year":"2006","unstructured":"De Valle MB, Av Klinteberg V, Alem N, et al. Drug-induced liver injury in a Swedish University hospital out-patient hepatology clinic. Aliment Pharmacol Ther. 2006;24:1187\u201395.","journal-title":"Aliment Pharmacol Ther"},{"key":"45_CR4","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1016\/j.gastro.2005.05.006","volume":"129","author":"RJ Andrade","year":"2005","unstructured":"Andrade RJ, Lucena MI, Fernandez MC, et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology. 2005;129:512\u201321.","journal-title":"Gastroenterology"},{"key":"45_CR5","doi-asserted-by":"crossref","first-page":"182","DOI":"10.1097\/MPG.0b013e31821d6cfd","volume":"53","author":"JP Molleston","year":"2011","unstructured":"Molleston JP, Fontana RJ, Lopez MJ, et al. Characteristics of idiosyncratic drug-induced liver injury in children: results from the DILIN prospective study. J Pediatr Gastroenterol Nutr. 2011;53:182\u20139.","journal-title":"J Pediatr Gastroenterol Nutr"},{"key":"45_CR6","doi-asserted-by":"crossref","first-page":"1176","DOI":"10.1002\/pds.1836","volume":"18","author":"G Trifiro","year":"2009","unstructured":"Trifiro G, Pariente A, Coloma PM, et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf. 2009;18:1176\u201384.","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"45_CR7","doi-asserted-by":"crossref","first-page":"1388","DOI":"10.1542\/peds.2006-1212","volume":"118","author":"JB Schwimmer","year":"2006","unstructured":"Schwimmer JB, Deutsch R, Kahen T, et al. Prevalence of fatty liver in children and adolescents. Pediatrics. 2006;118:1388\u201393.","journal-title":"Pediatrics"},{"key":"45_CR8","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1093\/pubmed\/fdg060","volume":"25","author":"C Cricelli","year":"2003","unstructured":"Cricelli C, Mazzaglia G, Samani F, et al. Prevalence estimates for chronic diseases in Italy: exploring the differences between self-report and primary care databases. J Public Health Med. 2003;25:254\u20137.","journal-title":"J Public Health Med"},{"key":"45_CR9","doi-asserted-by":"crossref","first-page":"2093","DOI":"10.1097\/01.hjh.0000186832.41125.8a","volume":"23","author":"G Mazzaglia","year":"2005","unstructured":"Mazzaglia G, Mantovani LG, Sturkenboom MC, et al. Patterns of persistence with antihypertensive medications in newly diagnosed hypertensive patients in Italy: a retrospective cohort study in primary care. J Hypertens. 2005;23:2093\u2013100.","journal-title":"J Hypertens"},{"key":"45_CR10","doi-asserted-by":"crossref","first-page":"243","DOI":"10.1016\/j.phrs.2010.04.006","volume":"62","author":"A Neubert","year":"2010","unstructured":"Neubert A, Verhamme K, Murray ML, et al. The prescribing of analgesics and non-steroidal anti-inflammatory drugs in paediatric primary care in the UK, Italy and The Netherlands. Pharmacol Res. 2010;62:243\u20138.","journal-title":"Pharmacol Res."},{"key":"45_CR11","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1007\/s00431-010-1275-7","volume":"170","author":"EF Sen","year":"2011","unstructured":"Sen EF, Verhamme KM, Neubert A, et al. Assessment of pediatric asthma drug use in three European countries; a TEDDY study. Eur J Pediatr. 2011;170:81\u201392.","journal-title":"Eur J Pediatr"},{"key":"45_CR12","doi-asserted-by":"crossref","unstructured":"Sturkenboom MC, Verhamme KM, Nicolosi A, et al. Drug use in children: cohort study in three European countries. BMJ (Clin Res Edn.) 2008;337:a2245.","DOI":"10.1136\/bmj.a2245"},{"key":"45_CR13","doi-asserted-by":"crossref","unstructured":"van Soest EM, Valkhoff VE, Mazzaglia G, et al. Suboptimal gastroprotective coverage of NSAID use and the risk of upper gastrointestinal bleeding and ulcers: an observational study using three European databases. Gut. 2011;60(12):1650\u20139.","DOI":"10.1136\/gut.2011.239848"},{"key":"45_CR14","doi-asserted-by":"crossref","unstructured":"Charlton M, Angulo P, Chalasani N, et al. Low circulating levels of dehydroepiandrosterone in histologically advanced nonalcoholic fatty liver disease. Hepatology (Baltimore). 2008;47:484\u201392.","DOI":"10.1002\/hep.22063"},{"key":"45_CR15","unstructured":"Standardization of definitions and criteria of causality assessment of adverse drug reactions. Drug-induced liver disorders: report of an international consensus meeting. Int J Clin Pharmacol Ther Toxicol. 1990;28:317\u201322."},{"key":"45_CR16","doi-asserted-by":"crossref","first-page":"272","DOI":"10.1016\/0168-8278(90)90124-A","volume":"11","author":"C Benichou","year":"1990","unstructured":"Benichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol. 1990;11:272\u20136.","journal-title":"J Hepatol"},{"key":"45_CR17","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1111\/j.1365-2125.2004.02133.x","volume":"58","author":"FJ Abajo de","year":"2004","unstructured":"de Abajo FJ, Montero D, Madurga M, et al. Acute and clinically relevant drug-induced liver injury: a population based case\u2013control study. Br J Clin Pharmacol. 2004;58:71\u201380.","journal-title":"Br J Clin Pharmacol"},{"key":"45_CR18","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1002\/(SICI)1099-1557(199907)8:4<275::AID-PDS427>3.0.CO;2-D","volume":"8","author":"MS Duh","year":"1999","unstructured":"Duh MS, Walker AM, Kronlund KH Jr. Descriptive epidemiology of acute liver enzyme abnormalities in the general population of central Massachusetts. Pharmacoepidemiol Drug Saf. 1999;8:275\u201383.","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"45_CR19","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1111\/j.1472-8206.2008.00566.x","volume":"22","author":"MI Lucena","year":"2008","unstructured":"Lucena MI, Garcia-Cortes M, Cueto R, et al. Assessment of drug-induced liver injury in clinical practice. Fundam Clin Pharmacol. 2008;22:141\u201358.","journal-title":"Fundam Clin Pharmacol"},{"key":"45_CR20","doi-asserted-by":"crossref","unstructured":"Traversa G, Bianchi C, Da Cas R, et al. Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs. BMJ (Clin Res Edn). 2003;327:18\u201322.","DOI":"10.1136\/bmj.327.7405.18"},{"key":"45_CR21","doi-asserted-by":"crossref","unstructured":"Suzuki A, Brunt EM, Kleiner DE, et al. The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis versus drug-induced liver injury. Hepatology (Baltimore). 2011;54:931\u20139.","DOI":"10.1002\/hep.24481"},{"key":"45_CR22","doi-asserted-by":"crossref","first-page":"731","DOI":"10.1056\/NEJMra052270","volume":"354","author":"VJ Navarro","year":"2006","unstructured":"Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med. 2006;354:731\u20139.","journal-title":"N Engl J Med."},{"key":"45_CR23","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1002\/pds.2053","volume":"20","author":"PM Coloma","year":"2011","unstructured":"Coloma PM, Schuemie MJ, Trifiro G, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf. 2011;20:1\u201311.","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"45_CR24","doi-asserted-by":"crossref","first-page":"292","DOI":"10.1002\/pds.2051","volume":"20","author":"MJ Schuemie","year":"2011","unstructured":"Schuemie MJ. Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD. Pharmacoepidemiol Drug Saf. 2011;20:292\u20139.","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"45_CR25","first-page":"25","volume":"166","author":"G Trifiro","year":"2011","unstructured":"Trifiro G, Patadia V, Schuemie MJ, et al. EU-ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection. Stud Health Technol Inform. 2011;166:25\u201330.","journal-title":"Stud Health Technol Inform."},{"key":"45_CR26","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1055\/s-0029-1240002","volume":"29","author":"LN Bell","year":"2009","unstructured":"Bell LN, Chalasani N. Epidemiology of idiosyncratic drug-induced liver injury. Semin Liver Dis. 2009;29:337\u201347.","journal-title":"Semin Liver Dis"},{"key":"45_CR27","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1097\/01.meg.0000250581.77865.68","volume":"19","author":"SH Hussaini","year":"2007","unstructured":"Hussaini SH, O\u2019Brien CS, Despott EJ, et al. Antibiotic therapy: a major cause of drug-induced jaundice in southwest England. Eur J Gastroenterol Hepatol. 2007;19:15\u201320.","journal-title":"Eur J Gastroenterol Hepatol"},{"key":"45_CR28","doi-asserted-by":"crossref","first-page":"947","DOI":"10.7326\/0003-4819-137-12-200212170-00007","volume":"137","author":"G Ostapowicz","year":"2002","unstructured":"Ostapowicz G, Fontana RJ, Schiodt FV, et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002;137:947\u201354.","journal-title":"Ann Intern Med"},{"key":"45_CR29","doi-asserted-by":"crossref","unstructured":"Sgro C, Clinard F, Ouazir K, et al. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology (Baltimore) 2002;36:451\u20135.","DOI":"10.1053\/jhep.2002.34857"},{"key":"45_CR30","doi-asserted-by":"crossref","unstructured":"Nicastro E, Ranucci G, Vajro P, et al. Re-evaluation of the diagnostic criteria for Wilson disease in children with mild liver disease. Hepatology (Baltimore) 2010;52:1948\u201356.","DOI":"10.1002\/hep.23910"},{"key":"45_CR31","doi-asserted-by":"crossref","first-page":"721","DOI":"10.1111\/j.1365-2125.2010.03754.x","volume":"70","author":"C Ferrajolo","year":"2010","unstructured":"Ferrajolo C, Capuano A, Verhamme KM, et al. Drug-induced hepatic injury in children: a case\/non-case study of suspected adverse drug reactions in VigiBase. Br J Clin Pharmacol. 2010;70:721\u20138.","journal-title":"Br J Clin Pharmacol"},{"key":"45_CR32","doi-asserted-by":"crossref","first-page":"250","DOI":"10.1016\/j.pharmthera.2008.02.005","volume":"118","author":"RN Hines","year":"2008","unstructured":"Hines RN. The ontogeny of drug metabolism enzymes and implications for adverse drug events. Pharmacol Ther. 2008;118:250\u201367.","journal-title":"Pharmacol Ther"},{"key":"45_CR33","doi-asserted-by":"crossref","first-page":"395","DOI":"10.1097\/MPG.0b013e3181709464","volume":"47","author":"KF Murray","year":"2008","unstructured":"Murray KF, Hadzic N, Wirth S, et al. Drug-related hepatotoxicity and acute liver failure. J Pediatr Gastroenterol Nutr. 2008;47:395\u2013405.","journal-title":"J Pediatr Gastroenterol Nutr"},{"key":"45_CR34","doi-asserted-by":"crossref","first-page":"1097","DOI":"10.1542\/peds.113.S3.1097","volume":"113","author":"VM Pineiro-Carrero","year":"2004","unstructured":"Pineiro-Carrero VM, Pineiro EO. Liver. Pediatrics. 2004;113:1097\u2013106.","journal-title":"Pediatrics."},{"key":"45_CR35","doi-asserted-by":"crossref","unstructured":"Garcia Rodriguez LA, Stricker BH, Zimmerman HJ. Risk of acute liver injury associated with the combination of amoxicillin and clavulanic acid. Arch Intern Med. 1996;156:1327\u201332.","DOI":"10.1001\/archinte.156.12.1327"},{"key":"45_CR36","doi-asserted-by":"crossref","first-page":"121","DOI":"10.1093\/jac\/dkm111","volume":"60","author":"F Salvo","year":"2007","unstructured":"Salvo F, Polimeni G, Moretti U, et al. Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy. J Antimicrob Chemother. 2007;60:121\u20136.","journal-title":"J Antimicrob Chemother"},{"key":"45_CR37","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1053\/j.gastro.2011.04.001","volume":"141","author":"MI Lucena","year":"2011","unstructured":"Lucena MI, Molokhia M, Shen Y, et al. Susceptibility to amoxicillin-clavulanate-induced liver injury is influenced by multiple HLA class I and II alleles. Gastroenterology. 2011;141:338\u201347.","journal-title":"Gastroenterology"},{"key":"45_CR38","unstructured":"Cuzzolin L, Antonucci R, Fanos V. Paracetamol (Acetaminophen) Efficacy and Safety in the Newborn. Curr Drug Metabol. 2012;14(2):178\u201385."},{"key":"45_CR39","unstructured":"Observational Medical Outcomes Partnership (OMOP). Available from URL: http:\/\/omop.fnih.org . Accessed 23 Feb 2011."},{"key":"45_CR40","doi-asserted-by":"crossref","first-page":"1257","DOI":"10.1038\/sj.ijo.0802734","volume":"28","author":"DF Chan","year":"2004","unstructured":"Chan DF, Li AM, Chu WC, et al. Hepatic steatosis in obese Chinese children. Int J Obes Relat Metab Disord. 2004;28:1257\u201363.","journal-title":"Int J Obes Relat Metab Disord"},{"key":"45_CR41","doi-asserted-by":"crossref","unstructured":"Nobili V, Marcellini M, Devito R, et al. NAFLD in children: a prospective clinical\u2013pathological study and effect of lifestyle advice. Hepatology (Baltimore). 2006;44:458\u201365.","DOI":"10.1002\/hep.21262"},{"key":"45_CR42","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1097\/00005176-200001000-00017","volume":"30","author":"M Rashid","year":"2000","unstructured":"Rashid M, Roberts EA. Nonalcoholic steatohepatitis in children. J Pediatr Gastroenterol Nutr. 2000;30:48\u201353.","journal-title":"J Pediatr Gastroenterol Nutr"},{"key":"45_CR43","doi-asserted-by":"crossref","unstructured":"Schwimmer JB, Behling C, Newbury R, et al. Histopathology of pediatric nonalcoholic fatty liver disease. Hepatology (Baltimore). 2005;42:641\u20139.","DOI":"10.1002\/hep.20842"}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-013-0045-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s40264-013-0045-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-013-0045-7","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,13]],"date-time":"2022-02-13T22:54:21Z","timestamp":1644792861000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s40264-013-0045-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,4,17]]},"references-count":43,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2013,10]]}},"alternative-id":["45"],"URL":"https:\/\/doi.org\/10.1007\/s40264-013-0045-7","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,4,17]]}}}