Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases

Drug Safety

Volumn 40, Issue 4, 2017, Pages 305-315

  Ferrajolo, Carmen ^a,b   Verhamme, Katia M C ^b   Trifirò, Gianluca ^b,c   ‘t Jong, Geert W ^b,d   Picelli, Gino ^e   Giaquinto, Carlo ^e,f   Mazzaglia, Giampiero ^g   Stricker, Bruno H ^b   Rossi, Francesco ^a   Capuano, Annalisa ^a   Sturkenboom, Miriam C J M ^b  

^a SECOND UNIVERSITY OF NAPLES   (Italy)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c UNIVERSITY OF MESSINA   (Italy)

^d UNIVERSITY OF MANITOBA   (Canada)

^e Pedianet Societa' Servizi Telematici SRL   (Italy)

^f UNIVERSITY OF PADOVA   (Italy)

^g Italian College of General Practitioners   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; AZITHROMYCIN; CEFACLOR; CEFIXIME; CEFPODOXIME; CEFTIBUTEN; CEFTRIAXONE; CEFUROXIME; CLARITHROMYCIN; COTRIMOXAZOLE; MACROLIDE; ROKITAMYCIN; SULFAMETHOXAZOLE; SULFONAMIDE; TRIMETHOPRIM; ANTIINFECTIVE AGENT;

ADOLESCENT; ALCOHOL CONSUMPTION; ARTICLE; CHILD; COMORBIDITY; CONTROLLED STUDY; DIABETES MELLITUS; DRUG EXPOSURE; DRUG SAFETY; FEMALE; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; HYPERTHYROIDISM; HYPOGLYCEMIA; HYPOTHYROIDISM; ITALY; LIVER INJURY; MAJOR CLINICAL STUDY; MALE; MULTIVARIATE LOGISTIC REGRESSION ANALYSIS; NETHERLANDS; NUTRITIONAL DISORDER; OBESITY; OUTPATIENT; PEDIATRICS; POPULATION BASED CASE CONTROL STUDY; PRESCRIPTION; PRIORITY JOURNAL; RISK ASSESSMENT; SMOKING; CASE CONTROL STUDY; DATA MINING; FACTUAL DATABASE; INFANT; MULTIVARIATE ANALYSIS; PRESCHOOL CHILD; PRIMARY HEALTH CARE; PROCEDURES; STATISTICAL MODEL; STATISTICS AND NUMERICAL DATA; TOXIC HEPATITIS;

ADOLESCENT; ANTI-BACTERIAL AGENTS; CASE-CONTROL STUDIES; CHEMICAL AND DRUG INDUCED LIVER INJURY; CHILD; CHILD, PRESCHOOL; DATA MINING; DATABASES, FACTUAL; FEMALE; HUMANS; INFANT; LOGISTIC MODELS; MALE; MULTIVARIATE ANALYSIS; PRIMARY HEALTH CARE; RISK ASSESSMENT;

EID: 85007155225     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-016-0493-y     Document Type: Article

References (50)

1. 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(5):721–8.
2. Ferrajolo C, Verhamme KM, Trifiro G, et al. Idiopathic acute liver injury in paediatric outpatients: incidence and signal detection in two european countries. Drug Saf. 2013;36(10):1007–16.
3. Meier Y, Cavallaro M, Roos M, et al. Incidence of drug-induced liver injury in medical inpatients. Eur J Clin Pharmacol. 2005;61(2):135–43.
4. Robles M, Toscano E, Cotta J, et al. Antibiotic-induced liver toxicity: mechanisms, clinical features and causality assessment. Curr Drug Saf. 2010;5(3):212–22.
5. Leitner JM, Graninger W, Thalhammer F. Hepatotoxicity of antibacterials: pathomechanisms and clinical. Infection. 2010;38(1):3–11.
6. Andrade RJ, Tulkens PM. Hepatic safety of antibiotics used in primary care. J Antimicrob Chemother. 2011;66(7):1431–46.
7. Serranti D, Montagnani C, Indolfi G, et al. Antibiotic induced liver injury: what about children? J Chemother. 2013;25(5):255–72.
8. Pineiro-Carrero VM, Pineiro EO. Liver. Pediatrics. 2004;113(4 Suppl):1097–106.
9. Devarbhavi H, Karanth D, Prasanna KS, et al. Drug-induced liver injury with hypersensitivity features has a better outcome: a single-center experience of 39 children and adolescents. Hepatology. 2011;54(4):1344–50.
10. Ferrajolo C, Coloma PM, Verhamme KM, et al. Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network. Drug Saf. 2014;37(2):99–108.
11. 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(2):182–9.
12. Mazzitello C, Esposito S, De Francesco AE, et al. Pharmacovigilance in italy: an overview. J Pharmacol Pharmacother. 2013;4(Suppl 1):S20–8.
13. de Bie S, Ferrajolo C, Straus SM, et al. Pediatric drug safety surveillance in FDA-AERS: a description of adverse events from grip project. PLoS One. 2015;10(6):e0130399.
14. Ferrajolo C, Capuano A, Trifiro G, et al. Pediatric drug safety surveillance in italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001–2012. Expert Opin Drug Saf. 2014;13(Suppl 1):S9–20.
15. Sturkenboom MC, Verhamme KM, Nicolosi A, et al. Drug use in children: cohort study in three european countries. BMJ. 2008;337:a2245.
16. Valkhoff VE, van Soest EM, Mazzaglia G, et al. Adherence to gastroprotection during cyclooxygenase 2 inhibitor treatment and the risk of upper gastrointestinal tract events: a population-based study. Arthritis Rheum. 2012;64(8):2792–802.
17. 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(1):81–92.
18. Masclee GM, Valkhoff VE, van Soest EM, et al. Cyclo-oxygenase-2 inhibitors or nonselective nsaids plus gastroprotective agents: what to prescribe in daily clinical practice? Aliment Pharmacol Ther. 2013;38(2):178–89.
19. Valkhoff VE, Schade R, t Jong GW, et al. Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues? BMC Pediatr. 2013;13:192.
20. 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(8):317–322.
21. Benichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol. 1990;11(2):272–6.
22. Brauer R, Douglas I, Garcia Rodriguez LA, et al. Risk of acute liver injury associated with use of antibiotics. Comparative cohort and nested case-control studies using two primary care databases in europe. Pharmacoepidemiol Drug Saf. 2016;25(Suppl 1):29–38.
23. Ruigomez A, Brauer R, Rodriguez LA, et al. Ascertainment of acute liver injury in two european primary care databases. Eur J Clin Pharmacol. 2014;70(10):1227–35.
24. Traversa G, Bianchi C, Da Cas R, et al. Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs. BMJ. 2003;327(7405):18–22.
25. de Abajo FJ, Montero D, Madurga M, et al. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br J Clin Pharmacol. 2004;58(1):71–80.
26. Walker AM. Observation and inference: an introduction to the methods of epidemiology. J Epidemiol Community Health. 1992;46(2):174.
27. Greenland S. Modeling and variable selection in epidemiologic analysis. Am J Public Health. 1989;79(3):340–9.
28. Bertuola F, Morando C, Menniti-Ippolito F, et al. Association between drug and vaccine use and acute immune thrombocytopenia in childhood: a case-control study in Italy. Drug Saf. 2010;33(1):65–72.
29. Bianciotto M, Chiappini E, Raffaldi I, et al. Drug use and upper gastrointestinal complications in children: a case-control study. Arch Dis Child. 2013;98(3):218–21.
30. Trifiro G, Gambassi G, Sen EF, et al. Association of community-acquired pneumonia with antipsychotic drug use in elderly patients: a nested case-control study. Ann Intern Med. 2010;152(7):418–425, W139–440.
31. Piovani D, Clavenna A, Bonati M. Review of italian primary care paediatricians identifies 38 commonly prescribed drugs for children. Acta Paediatr. 2014;103(12):e532–7.
32. 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(12):1327–32.
33. Ammann R, Neftel K, Hardmeier T, et al. Cephalosporin-induced cholestatic jaundice. Lancet. 1982;2(8293):336–7.
34. Brown SJ, Desmond PV. Hepatotoxicity of antimicrobial agents. Semin Liver Dis. 2002;22(2):157–67.
35. Paterson JM, Mamdani MM, Manno M, et al. Fluoroquinolone therapy and idiosyncratic acute liver injury: a population-based study. CMAJ. 2012;184(14):1565–70.
36. Polson JE. Hepatotoxicity due to antibiotics. Clin Liver Dis. 2007;11(3):549–561, vi.
37. Bell MJ, Stockwell DC, Luban NL, et al. Ceftriaxone-induced hemolytic anemia and hepatitis in an adolescent with hemoglobin sc disease. Pediatr Crit Care Med. 2005;6(3):363–6.
38. Longo F, Hastier P, Buckley MJ, et al. Acute hepatitis, autoimmune hemolytic anemia, and erythroblastocytopenia induced by ceftriaxone. Am J Gastroenterol. 1998;93(5):836–7.
39. Peker E, Cagan E, Dogan M. Ceftriaxone-induced toxic hepatitis. World J Gastroenterol. 2009;15(21):2669–71.
40. Dujovne CA, Chan CH, Zimmerman HJ. Sulfonamide hepatic injury. Review of the literature and report of a case due to sulfamethoxazole. N Engl J Med. 1967;277(15):785–8.
41. Mainra RR, Card SE. Trimethoprim-sulfamethoxazole-associated hepatotoxicity: part of a hypersensitivity syndrome. Can J Clin Pharmacol. 2003;10(4):175–8.
42. Abusin S, Johnson S. Sulfamethoxazole/trimethoprim induced liver failure: a case report. Cases J. 2008;1(1):44.
43. Bell TL, Foster JN, Townsend ML. Trimethoprim-sulfamethoxazole-induced hepatotoxicity in a pediatric patient. Pharmacotherapy. 2010;30(5):539.
44. Christopher K, Hyatt PA, Horkan C, et al. Clarithromycin use preceding fulminant hepatic failure. Am J Gastroenterol. 2002;97(2):489–90.
45. Principi N, Esposito S. Comparative tolerability of erythromycin and newer macrolide antibacterials in paediatric patients. Drug Saf. 1999;20(1):25–41.
46. Shaheen N, Grimm IS. Fulminant hepatic failure associated with clarithromycin. Am J Gastroenterol. 1996;91(2):394–5.
47. Mitsuyasu R, Groopman J, Volberding P. Cutaneous reaction to trimethoprim-sulfamethoxazole in patients with aids and kaposi’s sarcoma. N Engl J Med. 1983;308(25):1535–6.
48. Pullen H, Wright N, Murdoch JM. Hypersensitivity reactions to antibacterial drugs in infectious mononucleosis. Lancet. 1967;2(7527):1176–8.
49. Uetrecht J, Naisbitt DJ. Idiosyncratic adverse drug reactions: current concepts. Pharmacol Rev. 2013;65(2):779–808.
50. Russmann S, Kullak-Ublick GA, Grattagliano I. Current concepts of mechanisms in drug-induced hepatotoxicity. Curr Med Chem. 2009;16(23):3041–53.