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

doi:https://doi.org/10.1007/s40264-013-0132-9

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 journal › Article › Academic › peer-review

Abstract

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 language	English
Pages (from-to)	99-108
Number of pages	10
Journal	Drug Safety
Volume	37
Issue number	2
DOIs	https://doi.org/10.1007/s40264-013-0132-9
Publication status	Published - 2014

Keywords

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

Access to Document

https://doi.org/10.1007/s40264-013-0132-9

https://www.ncbi.nlm.nih.gov/pubmed/24446276

Cite this

Ferrajolo, C., Coloma, P. M., Verhamme, K. M., Schuemie, M. J., de Bie, S., Gini, R., Herings, R., Mazzaglia, G., Picelli, G., Giaquinto, C., Scotti, L., Avillach, P., Pedersen, L., Rossi, F., Capuano, A., van der Lei, J., Trifiro, G., Sturkenboom, M. C., & consortium, E.-A. (2014). Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network. Drug Safety, 37(2), 99-108. https://doi.org/10.1007/s40264-013-0132-9

@article{381964c397b34c47a98a3c6ad174c7e8,

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

abstract = "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",

keywords = "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",

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

note = "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 Trifiro, Gianluca Sturkenboom, Miriam C J M eng Research Support, Non-U.S. Gov't New Zealand Drug Saf. 2014 Feb;37(2):99-108. doi: 10.1007/s40264-013-0132-9.",

year = "2014",

doi = "https://doi.org/10.1007/s40264-013-0132-9",

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volume = "37",

pages = "99--108",

journal = "Drug Safety",

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Ferrajolo, C, Coloma, PM, Verhamme, KM, Schuemie, MJ, de Bie, S, Gini, R, Herings, R, Mazzaglia, G, Picelli, G, Giaquinto, C, Scotti, L, Avillach, P, Pedersen, L, Rossi, F, Capuano, A, van der Lei, J, Trifiro, G, Sturkenboom, MC & consortium, E-A 2014, 'Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network', Drug Safety, vol. 37, no. 2, pp. 99-108. https://doi.org/10.1007/s40264-013-0132-9

TY - JOUR

T1 - Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network

AU - Ferrajolo, C.

AU - Coloma, P. M.

AU - Verhamme, K. M.

AU - Schuemie, M. J.

AU - de Bie, S.

AU - Gini, R.

AU - Herings, R.

AU - Mazzaglia, G.

AU - Picelli, G.

AU - Giaquinto, C.

AU - Scotti, L.

AU - Avillach, P.

AU - Pedersen, L.

AU - Rossi, F.

AU - Capuano, A.

AU - van der Lei, J.

AU - Trifiro, G.

AU - Sturkenboom, M. C.

AU - consortium, Eu-Adr

N1 - 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 Trifiro, Gianluca Sturkenboom, Miriam C J M eng Research Support, Non-U.S. Gov't New Zealand Drug Saf. 2014 Feb;37(2):99-108. doi: 10.1007/s40264-013-0132-9.

PY - 2014

Y1 - 2014

N2 - 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

AB - 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

KW - 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

U2 - https://doi.org/10.1007/s40264-013-0132-9

DO - https://doi.org/10.1007/s40264-013-0132-9

M3 - Article

SN - 1179-1942

VL - 37

SP - 99

EP - 108

JO - Drug Safety

JF - Drug Safety

IS - 2

ER -