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

Li X, Tang J, Mao Y. Incidence and risk factors of drug-induced liver injury. Liver Int. 2022;42(9):1999–2014.

Article  PubMed  Google Scholar 

Watkins PB. Drug safety sciences and the bottleneck in drug development. Clin Pharmacol Ther. 2011;89(6):788–90.

Article  PubMed  CAS  Google Scholar 

Real M, Barnhill MS, Higley C, et al. Drug-induced liver injury: highlights of the recent literature. Drug Saf. 2019;42(3):365–87.

Article  PubMed  Google Scholar 

Clinton JW, Kiparizoska S, Aggarwal S, et al. Drug-induced liver injury: highlights and controversies in the recent literature. Drug Saf. 2021;44(11):1125–49.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Chen M, Suzuki A, Borlak J, et al. Drug-induced liver injury: Interactions between drug properties and host factors. J Hepatol. 2015;63(2):503–14.

Article  PubMed  CAS  Google Scholar 

Chalasani N, Bonkovsky HL, Fontana R, et al. Features and outcomes of 899 patients with drug-induced liver injury: the DILIN prospective study. Gastroenterology. 2015;148(7):1340-1352.e7.

Article  PubMed  Google Scholar 

Reuben A, Koch DG, Lee WM, et al. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology. 2010;52(6):2065–76.

Article  PubMed  Google Scholar 

Björnsson ES. Hepatotoxicity by drugs: the most common implicated agents. Int J Mol Sci. 2016;17(2):224.

Article  PubMed  PubMed Central  Google Scholar 

Au JS, Pockros PJ. Drug-induced liver injury from antiepileptic drugs. Clin Liver Dis. 2013;17(4):687–97.

Article  PubMed  Google Scholar 

Perucca E. Pharmacological and therapeutic properties of valproate: a summary after 35 years of clinical experience. CNS Drugs. 2002;16(10):695–714.

Article  PubMed  CAS  Google Scholar 

Lindquist M. VigiBase, the WHO global ICSR database system: basic facts. Drug Inf J. 2008;42(5):409–19.

Article  Google Scholar 

About VigiBase [Internet]. Available from: https://who-umc.org/vigibase/. Accessed 20 Aug 2023.

Petrović S, Kovačević M, Vezmar Kovačević S, et al. Drug-induced liver injury associated with the use of newer antiseizure medications in the elderly: an analysis of data from VigiBase. Expert Opin Drug Metab Toxicol. 2023;19(3):175–83.

Article  PubMed  Google Scholar 

Moore N, Berdaï D, Blin P, et al. Pharmacovigilance—the next chapter. Therapies. 2019;74(6):557–67.

Article  Google Scholar 

Bate A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009;18(6):427–36.

Article  PubMed  CAS  Google Scholar 

DuMouchel W, Pregibon D. Empirical bayes screening for multi-item associations. In: Proceedings of the seventh ACM SIGKDD international conference on Knowledge discovery and data mining. San Francisco, CA; 2001. p. 67–76.

Deshpande G, Gogolak V, Smith SW. Data mining in drug safety: review of published threshold criteria for defining signals of disproportionate reporting. Pharm Med. 2010;24(1):37–43.

Article  Google Scholar 

Kamitaki BK, Minacapelli CD, Zhang P, et al. Drug-induced liver injury associated with antiseizure medications from the FDA adverse event reporting system (FAERS). Epilepsy Behav. 2021;117: 107832.

Article  PubMed  Google Scholar 

Pal R, Singh K, Khan SA, et al. Reactive metabolites of the anticonvulsant drugs and approaches to minimize the adverse drug reaction. Eur J Med Chem. 2021;226: 113890.

Article  PubMed  CAS  Google Scholar 

Chen M, Borlak J, Tong W. A Model to predict severity of drug-induced liver injury in humans. Hepatology. 2016;64(3):931–40.

Article  PubMed  CAS  Google Scholar 

Stepan AF, Walker DP, Bauman J, et al. Structural alert/reactive metabolite concept as applied in medicinal chemistry to mitigate the risk of idiosyncratic drug toxicity: a perspective based on the critical examination of trends in the top 200 drugs marketed in the united states. Chem Res Toxicol. 2011;24(9):1345–410.

Article  PubMed  CAS  Google Scholar 

Finsterer J, Scorza FA. Effects of antiepileptic drugs on mitochondrial functions, morphology, kinetics, biogenesis, and survival. Epilepsy Res. 2017;136:5–11.

Article  PubMed  CAS  Google Scholar 

Santos NAG, Medina WSG, Martins NM, et al. Involvement of oxidative stress in the hepatotoxicity induced by aromatic antiepileptic drugs. Toxicol In Vitro. 2008;22(8):1820–4.

Article  PubMed  CAS  Google Scholar 

Felker D, Lynn A, Wang S, et al. Evidence for a potential protective effect of carnitine-pantothenic acid co-treatment on valproic acid-induced hepatotoxicity. Expert Rev Clin Pharmacol. 2014;7(2):211–8.

Article  PubMed  CAS  Google Scholar 

Strolin Benedetti M, Whomsley R, Baltes EL. Differences in absorption, distribution, metabolism and excretion of xenobiotics between the paediatric and adult populations. Expert Opin Drug Metab Toxicol. 2005;1(3):447–71.

Article  PubMed  CAS  Google Scholar 

Hunt CM, Yuen NA, Stirnadel-Farrant HA, et al. Age-related differences in reporting of drug-associated liver injury: data-mining of WHO safety report database. Regul Toxicol Pharmacol. 2014;70(2):519–26.

Article  PubMed  CAS  Google Scholar 

Zulfiqar Ali Q, Marques P, Selvarajah A, et al. Starting stiripentol in adults with Dravet syndrome? Watch for ammonia and carnitine. Epilepsia. 2020;61(11):2435–41.

Article  PubMed  CAS  Google Scholar 

Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43(11):707–24.

Article  PubMed  CAS  Google Scholar 

Sun W, He Y, Li Z, et al. Analysis of the clinical characteristics of the liver injury induced by levetiracetam. J Pharm Pharmacol. 2022;74(3):409–14.

Article  PubMed  Google Scholar 

Jain RS, Srivastava T, Sharma P, et al. Levetiracetam-mediated drug-induced liver injury—a rare presentation and review of literature. Ann Indian Acad Neurol. 2024;27(1):87–90.

Article  PubMed  Google Scholar 

Waxman DJ, Holloway MG. Sex differences in the expression of hepatic drug metabolizing enzymes. Mol Pharmacol. 2009;76(2):215–28.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Xu L, Yuan Y, Che Z, et al. The hepatoprotective and hepatotoxic roles of sex and sex-related hormones. Front Immunol. 2022;13: 939631.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Fromenty B, Pessayre D. Inhibition of mitochondrial beta-oxidation as a mechanism of hepatotoxicity. Pharmacol Ther. 1995;67(1):101–54.

Article  PubMed  CAS  Google Scholar 

Cho J, Kim L, Li Z, et al. Sex bias in experimental immune-mediated, drug-induced liver injury in BALB/c mice: suggested roles for Tregs, estrogen, and IL-6. PLoS ONE. 2013;8(4): e61186.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Andrade RJ, Lucena MI, Fernández MC, et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology. 2005;129(2):512–21.

Article  PubMed 

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