Evidence map›Paper›PMID 40465184›Full record

ArticleInternational journal of clinical pharmacy2025

Influence of patient age and sex on drug-induced liver injury caused by antiseizure medications: a disproportionality analysis of VigiBase.

Sanja Petrović, Milena Kovačević, Sandra Vezmar Kovačević, Branislava Miljković

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Article in International journal of clinical pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

4 authors.

Sanja PetrovićPrimeVigilance d.o.o, Đorđa Stanojevića 14, 11070, Belgrade, Serbia. ph.sanja.p@gmail.com.ORCID http://orcid.org/0000-0003-0421-2847
Milena KovačevićDepartment of Pharmacokinetics and Clinical Pharmacy, University of Belgrade - Faculty of Pharmacy, Belgrade, Serbia.ORCID http://orcid.org/0000-0003-2957-7965
Sandra Vezmar KovačevićDepartment of Pharmacokinetics and Clinical Pharmacy, University of Belgrade - Faculty of Pharmacy, Belgrade, Serbia.ORCID http://orcid.org/0000-0002-5791-2145
Branislava MiljkovićDepartment of Pharmacokinetics and Clinical Pharmacy, University of Belgrade - Faculty of Pharmacy, Belgrade, Serbia.ORCID http://orcid.org/0000-0001-5088-5976

Funding

Ministry of Science, Technological Development and Innovation, Republic of Serbia 451-03-136/2025-03/ 200161Ministry of Science, Technological Development and Innovation, Republic of Serbia No 451-03-137/2025-03/ 200161
6 · The paper itself

Abstract

backgroundWhile it has been recognised that children may be at a greater risk of developing valproic acid-induced hepatotoxicity, it is less known if age and sex represent risk factors for drug-induced liver injury (DILI) caused by other antiseizure medications (ASMs).

aimTo investigate the influence of patient age and sex on DILI caused by ASMs.

methodTo estimate hepatotoxic potential of 24 ASMs, deduplicated safety reports from VigiBase were accessed and disproportionality analysis was conducted by calculating Empirical Bayesian Geometric Mean and its 90% confidence interval (EB05, EB95). For ASMs with identified signals of disproportionate reporting (EB05 > 2, N > 0) for at least one hepatotoxicity-related event, we compared reporting frequency of overall hepatotoxicity among different age groups and between males and females by combining all events of interest into one custom term "overall DILI". The same analysis was conducted using the custom term "liver failure".

resultsSignals of disproportionate reporting were identified for 14 (58.33%) ASMs. Valproic acid and carbamazepine had the highest number of identified signals (25 and 17, respectively). Among the 14 ASMs with identified signals, seven (50%) had disproportionally higher reporting of overall DILI in children, one (7.14%) in older people, and nine (64.29%) in females. Further, six (42.86%) ASMs had disproportionally higher reporting of liver failure in children and three (21.43%) in females.

conclusionOur study suggests the importance of considering patient age and sex when assessing the risk of DILI from specific ASMs. However, the results are mainly hypothesis-generating and the identified signals require further investigation.

Indexed as

Adverse Drug Reaction Reporting SystemsAnticonvulsantsChemical and Drug Induced Liver InjuryAdolescentAdultAgedAge FactorsBayes TheoremChildChild, PreschoolFemaleHumansInfantMaleMiddle AgedRisk FactorsAnticonvulsantsValproic AcidAdverse drug reaction reporting systemsAge factorsAnticonvulsantsDrug-induced liver injurySex factors

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.