Background: Antibiotics have been associated with hepatotoxicity[1,2] but the risk has not been quantified in the pediatric population. Aim: To quantify the association between antibiotic use and hepatotoxicity in children and adolescents. Methods: We performed a population-based case-control study combining three European electronic primary care databases over the years 2000–2008: The Integrated Primary Care Information database in the Netherlands, plus the PEDIANET and Health Search/CSD Longitudinal Patient Database in Italy. Cases of hepatotoxicity in the paediatric population. Results: 1035 paediatric cases of hepatotoxicity were matched to 103 306 controls. Current use of antibiotics was associated with a 4-fold increased risk for hepatotoxicity compared to non-use [OR adj. 4.1 (95%CI, 3.2 to 5.3)]. Significant associations were found for current use of the following single agents: co-trimoxazole [OR adj 5.9 (2.3 to 15.1)]; rokitamycin (4.5, 1.4 to 15.0) and clarithromycin (3.2, 2.0 to 5.2) among macrolides; amoxicillin/clavulanic (2.6, 1.8 to 3.9) and amoxicillin (2.0, 1.3 to 3.1), among penicillins; and ceftriaxone (5.0, 2.0 to 12.7), cefuroxime (4.7, 1.4 to 15.2), ceftibuten (4.1, 1.8 to 9.4), cefpodoxime (3.6, 1.3 to 10.0), cefixime (3.5, 1.9 to 6.4) and cefaclor (2.7, 1.3 to 5.6), among cephalosporins. Except for rokitamycin, the associations remained significant when studying cases confirmed by specialist only. Conclusion: This study provides risk estimates of hepatotoxicity in children and adolescents using antibiotics. Current use of cotrimoxazole, some cephalosporins and macrolides and amoxicillin with or without clavulanic acid in paediatrics is associated with an increased risk for hepatotoxicity.

Ferrajolo, C., Verhamme, K., Trifiro, G., 't Jong, G., Picelli, G., Giaquinto, C., et al. (2012). Hepatic Safety of Antibiotics in Paediatric Primary Care: A Case-Control Study Using Electronic Healthcare Databases. Intervento presentato a: Annual Meeting of the International-Society-of-Pharmacovigilance (ISoP), Cancun, Mexico.

Hepatic Safety of Antibiotics in Paediatric Primary Care: A Case-Control Study Using Electronic Healthcare Databases

Mazzaglia G;
2012

Abstract

Background: Antibiotics have been associated with hepatotoxicity[1,2] but the risk has not been quantified in the pediatric population. Aim: To quantify the association between antibiotic use and hepatotoxicity in children and adolescents. Methods: We performed a population-based case-control study combining three European electronic primary care databases over the years 2000–2008: The Integrated Primary Care Information database in the Netherlands, plus the PEDIANET and Health Search/CSD Longitudinal Patient Database in Italy. Cases of hepatotoxicity in the paediatric population. Results: 1035 paediatric cases of hepatotoxicity were matched to 103 306 controls. Current use of antibiotics was associated with a 4-fold increased risk for hepatotoxicity compared to non-use [OR adj. 4.1 (95%CI, 3.2 to 5.3)]. Significant associations were found for current use of the following single agents: co-trimoxazole [OR adj 5.9 (2.3 to 15.1)]; rokitamycin (4.5, 1.4 to 15.0) and clarithromycin (3.2, 2.0 to 5.2) among macrolides; amoxicillin/clavulanic (2.6, 1.8 to 3.9) and amoxicillin (2.0, 1.3 to 3.1), among penicillins; and ceftriaxone (5.0, 2.0 to 12.7), cefuroxime (4.7, 1.4 to 15.2), ceftibuten (4.1, 1.8 to 9.4), cefpodoxime (3.6, 1.3 to 10.0), cefixime (3.5, 1.9 to 6.4) and cefaclor (2.7, 1.3 to 5.6), among cephalosporins. Except for rokitamycin, the associations remained significant when studying cases confirmed by specialist only. Conclusion: This study provides risk estimates of hepatotoxicity in children and adolescents using antibiotics. Current use of cotrimoxazole, some cephalosporins and macrolides and amoxicillin with or without clavulanic acid in paediatrics is associated with an increased risk for hepatotoxicity.
abstract
Liver Injury; Drug Safety; Child; Case-Control studies; Electronic Healthcare Databases
English
Annual Meeting of the International-Society-of-Pharmacovigilance (ISoP)
2012
2012
35
10
948
949
reserved
Ferrajolo, C., Verhamme, K., Trifiro, G., 't Jong, G., Picelli, G., Giaquinto, C., et al. (2012). Hepatic Safety of Antibiotics in Paediatric Primary Care: A Case-Control Study Using Electronic Healthcare Databases. Intervento presentato a: Annual Meeting of the International-Society-of-Pharmacovigilance (ISoP), Cancun, Mexico.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/225849
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