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

Drug Safety

Volumn 37, Issue 2, 2014, Pages 99-108

  Ferrajolo, Carmen ^a,b   Coloma, Preciosa M ^a   Verhamme, Katia M C ^a   Schuemie, Martijn J ^a   De Bie, Sandra ^a   Gini, Rosa ^c   Herings, Ron ^d   Mazzaglia, Giampiero ^e   Picelli, Gino ^f   Giaquinto, Carlo ^g   Scotti, Lorenza ^h   Avillach, Paul ⁱ   Pedersen, Lars ^j   Rossi, Francesco ^b   Capuano, Annalisa ^b   Van Der Lei, Johan ^a   Trifiro, Gianluca ^a,k   Sturkenboom, Miriam C J M ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b SECOND UNIVERSITY OF NAPLES   (Italy)

^c Regional Health Agency of Tuscany   (Italy)

^d PHARMO INSTITUTE FOR DRUG OUTCOMES RESEARCH   (Netherlands)

^e Italian College of General Practitioners   (Italy)

^f Pedianet Societa' Servizi Telematici SRL   (Italy)

^g UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^h UNIVERSITY OF MILANO BICOCCA   (Italy)

ⁱ UNIVERSITÉ DE BORDEAUX   (France)

^j AARHUS UNIVERSITY HOSPITAL   (Denmark)

^k UNIVERSITY OF MESSINA   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; AZATHIOPRINE; CEFACLOR; CETIRIZINE; CITALOPRAM; CLARITHROMYCIN; DICLOFENAC; DOMPERIDONE; ERYTHROMYCIN; FLUNISOLIDE; HUMAN INSULIN; METHOTREXATE; METOCLOPRAMIDE; OMEPRAZOLE; PENICILLIN V; PREDNISOLONE; PREDNISONE; RANITIDINE; VALPROIC ACID;

ACUTE DISEASE; ADULT; ARTICLE; CONTROLLED STUDY; DATA MINING; DISEASE ASSOCIATION; DRUG EXPOSURE; DRUG INDUCED ACUTE LIVER INJURY; DRUG INDUCED DISEASE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MEDLINE; PRESCRIPTION; PRIORITY JOURNAL; RISK FACTOR; SIGNAL DETECTION; TOXIC HEPATITIS; YOUNG ADULT;

ADOLESCENT; ADVERSE DRUG REACTION REPORTING SYSTEMS; CHILD; CHILD WELFARE; CHILD, PRESCHOOL; DATA MINING; DATABASES, FACTUAL; DRUG-INDUCED LIVER INJURY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ELECTRONIC HEALTH RECORDS; EUROPEAN UNION; HUMANS; INFANT; INFANT, NEWBORN; INTERNATIONAL COOPERATION; LIVER FAILURE, ACUTE;

EID: 84897944112     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-013-0132-9     Document Type: Article

References (36)

1. Ferrajolo C, Capuano A, Verhamme KM, Schuemie M, Rossi F, Stricker BH, 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. Stephenson WP, Hauben M. Data mining for signals in spontaneous reporting databases: proceed with caution. Pharmacoepidemiol Drug Saf. 2007;16(4):359-65.
3. Coloma PM, Avillach P, Salvo F, Schuemie MJ, Ferrajolo C, Pariente A, et al. A reference standard for evaluation of methods for drug safety signal detection using electronic healthcare record databases. Drug Saf. 2013;36(1):13-23.
4. Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol. 2005;58(4):323-37.
5. Platt R, Wilson M, Chan KA, Benner JS, Marchibroda J, McClellan M. The new Sentinel Network - improving the evidence of medical-product safety. N Engl J Med. 2009;361(7): 645-7.
6. Stang PE, Ryan PB, Racoosin JA, Overhage JM, Hartzema AG, Reich C, et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med. 2010;153(9):600-6.
7. Trifiro G, Pariente A, Coloma PM, Kors JA, Polimeni G, Miremont- Salame G, et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf. 2009;18(12):1176-84.
8. Trifiro G, Fourrier-Reglat A, Sturkenboom MC, Diaz Acedo C, Van Der Lei J. The EU-ADR project: preliminary results and perspective. Stud Health Technol Inform. 2009;148:43-9.
9. Coloma PM, Schuemie MJ, Trifiro G, Gini R, Herings R, Hippisley- Cox J, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EUADR Project. Pharmacoepidemiol Drug Saf. 2011;20(1):1-11.
10. Avillach P, Joubert M, Thiessard F, Trifiro G, Dufour JC, Pariente A, et al. Design and evaluation of a semantic approach for the homogeneous identification of events in eight patient databases: a contribution to the European EU-ADR project. Stud Health Technol Inform. 2010;160(Pt 2):1085-9.
11. Avillach P, Mougin F, Joubert M, Thiessard F, Pariente A, Dufour JC, et al. A semantic approach for the homogeneous identification of events in eight patient databases: a contribution to the European eu-ADR project. Stud Health Technol Inform. 2009;150:190-4.
12. Updated 4 April 2012; http://www.whocc.no/atc-ddd-index/.
13. Avillach P, Coloma PM, Gini R, Schuemie M, Mougin F, Dufour JC, et al. Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project. J Am Med Inform Assoc. 2013;20(1):184-92.
14. Schuemie MJ. Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD. Pharmacoepidemiol Drug Saf. 2011;20(3):292-9.
15. Schuemie MJ, Coloma PM, Straatman H, Herings RM, Trifiro G, Matthews JN, et al. Using electronic health care records for drug safety signal detection: a comparative evaluation of statistical methods. Med Care. 2012;50(10):890-7.
16. Slattery J, Alvarez Y, Hidalgo A. Choosing thresholds for statistical signal detection with the proportional reporting ratio. Drug Saf. 2013;36(8):687-92.
17. Hauben M, Aronson JK. Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf. 2009;32(2):99-110.
18. Kantar A, Mroueh S, Fiocchi A. A reappraisal of the clinical efficacy of nebulized flunisolide in pediatric asthma: the Italian experience. Allergy Asthma Proc. 2007;28(6):671-87.
19. Kelly HW. Establishing a therapeutic index for the inhaled corticosteroids: part I. Pharmacokinetic/pharmacodynamic comparison of the inhaled corticosteroids. J Allergy Clin Immunol. 1998;102(4 Pt 2):S36-51.
20. Todd GR, Acerini CL, Ross-Russell R, Zahra S, Warner JT, McCance D. Survey of adrenal crisis associated with inhaled corticosteroids in the United Kingdom. Arch Dis Child. 2002;87(6):457-61.
21. Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011;17(Suppl 2):1-53.
22. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364-79.
23. Powell EE, Cooksley WG, Hanson R, Searle J, Halliday JW, Powell LW. The natural history of nonalcoholic steatohepatitis: a follow-up study of forty-two patients for up to 21 years. Hepatology. 1990;11(1):74-80.
24. Bugianesi E, Moscatiello S, Ciaravella MF, Marchesini G. Insulin resistance in nonalcoholic fatty liver disease. Curr Pharm Des. 2010;16(17):1941-51.
25. Marchesini G, Brizi M, Morselli-Labate AM, Bianchi G, Bugianesi E, McCullough AJ, et al. Association of nonalcoholic fatty liver disease with insulin resistance. Am J Med. 1999;107(5):450-5.
26. Molleston JP, Fontana RJ, Lopez MJ, Kleiner DE, Gu J, Chalasani N. Characteristics of idiosyncratic drug-induced liver injury in children: results from the DILIN prospective study. J Pediatr Gastroenterol Nutr. 2011;53(2):182-9.
27. Ekiz F, Yuksel I, Ekiz O, Coban S, Basar O, Yuksel O. Levocetirizine induced hepatotoxicity in a patient with chronic urticaria. Ann Hepatol. 2011;10(2):237-8.
28. Jurawan R, Smith A. Severe hepatitis in a primary sclerosing cholangitis patient receiving recent cetirizine therapy. N Z Med J. 2010;123(1309):106-7.
29. Rodriguez-Gomez SJ, Zamora-Martinez T, Bailador-Andres C, Fuentes-Coronel AM, Martin-Arribas MI. Severe intrahepatic cholestasis associated with cetirizine. Gastroenterol Hepatol. 2009;32(5):383-4.
30. Pompili M, Basso M, Grieco A, Vecchio FM, Gasbarrini G, Rapaccini GL. Recurrent acute hepatitis associated with use of cetirizine. Ann Pharmacother. 2004;38(11):1844-7.
31. Sabate M, Ibanez L, Perez E, Vidal X, Buti M, Xiol X, et al. Risk of acute liver injury associated with the use of drugs: a multicentre population survey. Aliment Pharmacol Ther. 2007;25(12): 1401-9.
32. de Abajo FJ, Montero D, Madurga M, Garcia Rodriguez GA. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br J Clin Pharmacol. 2004; 58(1):71-80.
33. Ferrajolo C, Verhamme KM, Trifiro G, 't Jong GW, Giaquinto C, Picelli 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.
34. Sturkenboom MC, Verhamme KM, Nicolosi A, Murray ML, Neubert A, Caudri D, et al. Drug use in children: cohort study in three European countries. BMJ. 2008;337:a2245.
35. Reich CG, Ryan PB, Schuemie MJ. Alternative outcome definitions and their effect on the performance of methods for observational outcome studies. Drug Saf. 2013;36(Suppl 1):S181-93.
36. Walker AM. Orthogonal predictions: follow-up questions for suggestive data. Pharmacoepidemiol Drug Saf. 2010;19(5): 529-32.