Predicting idiosyncratic drug-induced liver injury-some recent advances

Expert Review of Gastroenterology and Hepatology

Volumn 8, Issue 7, 2014, Pages 721-723

  Chen, Minjun ^a   Borlak, Jürgen ^b   Tong, Weida ^a  

^a NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH   (United States)

^b HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

data integration; drug safety; HLA; idiosyncratic drug induced liver injury; predictive model

Indexed keywords

BIOLOGICAL MARKER; FLUCLOXACILLIN; PARACETAMOL; AMINOTRANSFERASE; BILIRUBIN; HLA B ANTIGEN; HLA-B*57:01 ANTIGEN;

ACUTE LIVER FAILURE; ADVERSE OUTCOME; DISEASE SEVERITY; DRUG SAFETY; HUMAN; INCIDENCE; LIVER INJURY; NONHUMAN; OUTCOME ASSESSMENT; PREDICTION; REVIEW; RISK ASSESSMENT; RISK FACTOR; TOXIC HEPATITIS; ANIMAL; BIOLOGICAL MODEL; BLOOD; DIAGNOSTIC TEST; DISEASE MODEL; DRUG-INDUCED LIVER INJURY; GENETIC SCREENING; GENETICS; GENOTYPE; PHARMACOGENETICS; PREDICTIVE VALUE; TRENDS;

ANIMALS; BILIRUBIN; BIOLOGICAL MARKERS; DIAGNOSTIC TESTS, ROUTINE; DISEASE MODELS, ANIMAL; DRUG-INDUCED LIVER INJURY; FLOXACILLIN; GENETIC TESTING; GENOTYPE; HLA-B ANTIGENS; HUMANS; MODELS, BIOLOGICAL; PHARMACOGENETICS; PREDICTIVE VALUE OF TESTS; RISK FACTORS; TRANSAMINASES;

EID: 84906351704     PISSN: 17474124     EISSN: 17474132     Source Type: Journal    
DOI: 10.1586/17474124.2014.922871     Document Type: Review

References (22)

1. Lee WM. Drug-induced acute liver failure. Clin Liver Dis 2013;17(4):575-86
2. Chen M, Vijay V, Shi Q, et al. FDA-approved drug labeling for the study of drug-induced liver injury. Drug Discov Today 2011;16(15-16):697-703
3. Roth RA, Ganey PE. Intrinsic versus idiosyncratic drug-induced hepatotoxicity-two villains or one? J Pharmacol Exp Ther 2010;332(3):692-7
4. Chen M, Bisgin H, Tong L, et al. Toward predictive models for drug-induced liver injury in humans: are we there yet? Biomark Med 2014;8(2):201-13
5. Lewis JH. Drug-induced liver injury, dosage, and drug disposition: is idiosyncrasy really unpredictable? Clin Gastroenterol Hepatol 2014. [Epub ahead of print]
6. Daly AK, Donaldson PT, Bhatnagar P, et al. HLA-B* 5701 genotype is a major determinant of drug-induced liver injury due to flucloxacillin. Nat Genet 2009;41(7): 816-19
7. Urban TJ, Shen Y, Stolz A, et al. Limited contribution of common genetic variants to risk for liver injury due to a variety of drugs. Pharmacogenet Genomics 2012; 22(11):784
8. Antoine DJ, Dear JW, Lewis PS, et al. Mechanistic biomarkers provide early and sensitive detection of acetaminophen-induced acute liver injury at first presentation to hospital. Hepatology 2013;58(2):777-87
9. Nonclinical assessment of potential hepatotoxicity in man. Available from: www.fda.gov/downloads/drugs/scienceresearch/researchareas/ucm091453.pdf [Last accessed March 2014]
10. Olson H, Betton G, Robinson D, et al. Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul Toxicol Pharmacol 2000;32(1):56-67
11. Bjornsson ES, Bergmann OM, Bjornsson HK, et al. Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology 2013;144(7):1419-25.e1413
12. Garcia-Cortes M, Stephens C, Lucena MI, et al. Causality assessment methods in drug induced liver injury: strengths and weaknesses. J Hepatol 2011;55(3):683-91
13. Teschke R, Frenzel C, Wolff A, et al. Drug induced liver injury: accuracy of diagnosis in published reports. Ann Hepatol 2014;13(2): 248-55
14. Anderson N, Borlak J. Correlation versus causation? Pharmacovigilance of the analgesic flupirtine exemplifies the need for refined spontaneous ADR reporting. PLoS One 2011;6(10):e25221
15. Steuerwald NM, Foureau DM, Norton HJ, et al. Profiles of serum cytokines in acute drug-induced liver injury and their prognostic significance. PLoS One 2013; 8(12):e81974
16. Shaw PJ, Hopfensperger MJ, Ganey PE, Roth RA. Lipopolysaccharide and trovafloxacin coexposure in mice causes idiosyncrasy-like liver injury dependent on tumor necrosis factor-alpha. Toxicol Sci 2007;100(1):259-66
17. Cosgrove BD, King BM, Hasan MA, et al. Synergistic drug-cytokine induction of hepatocellular death as an in vitro approach for the study of inflammation-associated idiosyncratic drug hepatotoxicity. Toxicol Appl Pharmacol 2009;237(3):317-30
18. Senior JR. Alanine aminotransferase: a clinical and regulatory tool for detecting liver injury-past, present, and future. Clin Pharmacol Ther 2012;92(3):332-9
19. Guidance for industry drug-induced liver injury: premarketing clinical evaluation. Available from: www.fda.gov/downloads/Drugs/../Guidances/UCM174090. pdf [Last accessed March 2014]
20. Li AP. A review of the common properties of drugs with idiosyncratic hepatotoxicity and the "multiple determinant hypothesis" for the manifestation of idiosyncratic drug toxicity. Chem Biol Interact 2002;142(1-2): 7-23
21. Chen M, Zhang J, Wang Y, et al. Liver toxicity knowledge base (LTKB)-a systems approach to a complex endpoint. Clin Pharmacol Ther 2013;95(5):409-12
22. Chen M, Borlak J, Tong W. High lipophilicity and high daily dose of oral medications are associated with significant risk for drug-induced liver injury. Hepatology 2013;58(1):388-96