Causality assessment methods in drug induced liver injury: Strengths and weaknesses

Guidance for Industry. Drug-Induced Liver Injury: Premarketing Clinical Evaluation, July 2010. <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090>. Ostapowicz, 2002, Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States, Ann Intern Med, 137, 947, 10.7326/0003-4819-137-12-200212170-00007 Wei, 2007, Acute liver failure in Sweden: etiology and outcome, J Intern Med, 262, 393, 10.1111/j.1365-2796.2007.01818.x Andrade, 2005, Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period, Gastroenterology, 129, 512, 10.1016/j.gastro.2005.05.006 Fontana, 2009, Drug-induced liver injury network (DILIN) prospective study rationale, design and conduct, Drug Saf, 32, 55, 10.2165/00002018-200932010-00005 Daly, 2009, HLA-B∗5701 genotype is a major determinant of drug-induced liver injury due to flucloxacillin, Nat Genet, 41, 816, 10.1038/ng.379 Björnsson, 2005, Outcome and prognostic markers in severe drug-induced liver disease, Hepatology, 42, 481, 10.1002/hep.20800 Molokhia, 2006, EUDRAGENE: European collaboration to establish a case-control DNA collection for studying the genetic basis of adverse drug reactions, Pharmacogenomics, 7, 633, 10.2217/14622416.7.4.633 Andrade, 2006, Outcome of acute idiosyncratic drug-induced liver injury: long-term follow-up in a hepatotoxicity registry, Hepatology, 44, 1581, 10.1002/hep.21424 Fontana, 2010, Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop, Hepatology, 52, 730, 10.1002/hep.23696 Aithal, 2011, Case definition and phenotype standardization in drug-induced liver injury, Clin Pharmacol Ther, 89, 806, 10.1038/clpt.2011.58 Kramer, 1986, Assessing causality of adverse drug reactions: global introspection and its limitations, Drug Info J, 20, 433, 10.1177/009286158602000409 Arimone, 2005, Agreement of expert judgment in causality assessment of adverse drug reactions, Eur J Clin Pharmacol, 61, 169, 10.1007/s00228-004-0869-2 Macedo, 2006, Can decisional algorithms replace global introspection in the individual causality assessment of spontaneously reported ADRs?, Drug Saf, 29, 697, 10.2165/00002018-200629080-00006 Rockey, 2010, Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method, Hepatology, 51, 2117, 10.1002/hep.23577 Zapater, 2002, A new Poisson and Bayesian-based method to assign risk and causality in patients with suspected hepatic adverse drug reactions: a report of two new cases of ticlopidine-induced hepatotoxicity, Drug Saf, 25, 735, 10.2165/00002018-200225100-00006 Karch, 1977, Toward the operational identification of adverse drug reactions, Clin Pharmacol Ther, 21, 247, 10.1002/cpt1977213247 Naranjo, 1981, A method for estimating the probability of adverse drug reactions, Clin Pharmacol Ther, 30, 239, 10.1038/clpt.1981.154 García-Cortés, 2008, Evaluation of Naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury, Aliment Pharmacol Ther, 27, 780, 10.1111/j.1365-2036.2008.03655.x Stricker, 1992 Danan, 1993, . Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries, J Clin Epidemiol, 46, 1323, 10.1016/0895-4356(93)90101-6 Maria, 1997, Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis, Hepatology, 26, 664, 10.1002/hep.510260319 Takikawa, 2003, Assessment of 287 Japanese cases of drug induced liver injury by the diagnostic scale of the International Consensus Meeting, Hepatol Res, 27, 192, 10.1016/S1386-6346(03)00232-8 Benichou, 1990, Criteria of drug-induced liver disorders. Report of an international consensus meeting, J Hepatol, 11, 272, 10.1016/0168-8278(90)90124-A Benichou, 1993, Causality assessment of adverse reactions to drugs-II. An original model or validation of drug causality assessment methods: case reports with positive rechallenge, J Clin Epidemiol, 46, 1331, 10.1016/0895-4356(93)90102-7 Rochon, 2008, Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury, Hepatology, 48, 1175, 10.1002/hep.22442 Lucena, 2001, Comparison of two clinical scales for causality assessment in hepatotoxicity, Hepatology, 33, 123, 10.1053/jhep.2001.20645 Watanabe, 2004, Validity study of a new diagnostic scale for drug-induced liver injury in Japan-comparison with two previous scales, Hepatol Res, 30, 148, 10.1016/j.hepres.2004.08.005 Stephens, 2010, The HLA class I B∗1801 allele influences hepatocellular expression of amoxicillin–clavulanate liver damage and outcome in Spanish patients, J Hepatol, 52, S439, 10.1016/S0168-8278(10)61138-5 Watkins, 2009, Biomarkers for the diagnosis and management of drug-induced liver injury, Semin Liver Dis, 29, 393, 10.1055/s-0029-1240008 Aithal, 2000, Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions, J Hepatol, 33, 949, 10.1016/S0168-8278(00)80127-0 Tajiri, 2008, Practical guidelines for diagnosis and early management of drug-induced liver injury, World J Gastroenterol, 14, 6774, 10.3748/wjg.14.6774 Hayashi, 2009, Causality assessment in drug-induced liver injury, Sem Liv Dis, 29, 348, 10.1055/s-0029-1240003 Shapiro, 2007, Causality assessment of drug-induced hepatotoxicity: promises and pitfalls, Clin Liver Dis, 477, 10.1016/j.cld.2007.06.003 Lucena, 2006, Determinants of the clinical expression of amoxicillin–clavulanate hepatotoxicity: a prospective series from Spain, Hepatology, 44, 850, 10.1002/hep.21324 Lucena, 2009, Phenotypic characterization of idiosyncratic drug-induced liver injury: the influence of age and sex, Hepatology, 49, 2001, 10.1002/hep.22895 Fairley, 1993, Risk factors for development of flucloxacillin associated jaundice, BMJ, 306, 233, 10.1136/bmj.306.6872.233 Nolan, 1999, Hepatotoxicity associated with isoniazid preventive therapy: a 7-year survey from a public health tuberculosis clinic, JAMA, 281, 1014, 10.1001/jama.281.11.1014 Chalasani, 2010, Risk factors for idiosyncratic drug-induced liver injury, Gastroenterology, 138, 2246, 10.1053/j.gastro.2010.04.001 Andrade, 2009, Drug-induced liver injury: insights from genetic studies, Pharmacogenomics, 10, 1467, 10.2217/pgs.09.111 Lucena, 2006, Prolonged cholestasis after raloxifene ad fenofibrate interaction: a case report, World J Gastroenterol, 12, 5244 Verma, 2009, Diagnosis, management and prevention of drug-induced liver injury, Gut, 58, 1555, 10.1136/gut.2008.163675 Dalton, 2007, The role of hepatitis E virus testing in drug-induced liver injury, Aliment Pharmacol Ther, 26, 1429, 10.1111/j.1365-2036.2007.03504.x Suzuki, 2010, Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase™: unified list based on international collaborative work, Drug Saf, 33, 503, 10.2165/11535340-000000000-00000 Andrade, 2009, Rechallenge in drug-induced liver injury: the attractive hazard, Expert Opin Drug Saf, 8, 709, 10.1517/14740330903397378 Andrade, 2007, Assessment of drug-induced hepatotoxicity in clinical practice. a challenge for gastroenterologists, World J Gastroenterol, 13, 329, 10.3748/wjg.v13.i3.329 Kleiner, 2009, The pathology of drug-induced liver injury, Semin Liver Dis, 29, 364, 10.1055/s-0029-1240005 Larrey, 2002, Epidemiology and individual susceptibility to adverse drug reactions affecting the liver, Semin Liver Dis, 22, 145, 10.1055/s-2002-30105 Kaplowitz, 2001, Causality assessment versus guilt-by-association in drug hepatotoxicity, Hepatology, 33, 308, 10.1053/jhep.2001.21083