ArticleDrug safety2014
Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network.
Article in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
18 citing papers in PubMed, 30 citations in OpenAlex.
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- Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.Drug safety · 2023Article
- An industry perspective on the use of machine learning in drug and vaccine safety.Frontiers in drug safety and regulation · 2023Article
- Active Pharmacovigilance of Drug-Induced Liver Injury Using Electronic Health Records.Allergy, asthma & immunology research · 2020Article
- From Animal Poisons and Venoms to Medicines: Achievements, Challenges and Perspectives in Drug Discovery.Frontiers in pharmacology · 2020Review
- Developing a portable natural language processing based phenotyping system.BMC medical informatics and decision making · 2019Article
- The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?Drug safety · 2019Review
- Agreement Among Different Scales for Causality Assessment in Drug-Induced Liver Injury.Clinical drug investigation · 2018Observational
- Antidepressant-Induced Acute Liver Injury: A Case-Control Study in an Italian Inpatient Population.Drug safety · 2018Article
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- Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases.Drug safety · 2017Article
- The risk of acute liver injury among users of antibiotic medications: a comparison of case-only studies.Pharmacoepidemiology and drug safety · 2016Article
- Adverse drug reactions in neonates and infants: a population-tailored approach is needed.British journal of clinical pharmacology · 2015Article
- Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.World journal of hepatology · 2015Review
- Pediatric drug safety signal detection: a new drug-event reference set for performance testing of data-mining methods and systems.Drug safety · 2015Article
- Natural Language Processing for EHR-Based Computational Phenotyping.IEEE/ACM transactions on computational biology and bioinformaticsReview
Corrections and comments
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Authors and funding
19 authors at 8 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundData mining in spontaneous reporting databases has shown that drug-induced liver injury is infrequently reported in children.
objectivesOur 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.
methodsWe identified potential cases of ALI during exposure to any prescribed/dispensed drug for individuals <18 years old from the EU-ADR network, which includes seven databases from three countries, covering the years 1996-2010. Several new methods for signal detection were applied to identify all statistically significant associations between drugs and ALI. A drug was considered statistically significantly associated with ALI, using all other time as a reference category, if the 95% CI lower band of the relative risk was >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.
resultsThe study population comprised 4,838,146 individuals aged <18 years, who contributed an overall 25,575,132 person-years of follow-up. Within this population, we identified 1,015 potential cases of ALI. Overall, 20 positive drug-ALI associations were detected. The associations between ALI and domperidone, flunisolide and human insulin were considered as potentially new signals. Citalopram and cetirizine have been previously described as hepatotoxic in adults but not in children, while all remaining associations were already known in both adults and children.
conclusionsData mining of multiple EHR databases for signal detection confirmed known associations between ALI and several drugs, and identified some potentially new signals in children that require further investigation through formal epidemiologic studies. This study shows that EHRs may complement traditional spontaneous reporting systems for signal detection and strengthening.
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