Causality assessment: Which is best-expert opinion or RUCAM?

Clinical Liver Disease

Volumn 4, Issue 1, 2014, Pages 4-8

  Lewis, James H ^a  

^a GEORGETOWN UNIVERSITY HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; HALOTHANE; MINOCYCLINE; NITROFURANTOIN; TIENILIC ACID; XIMELAGATRAN;

ACUTE LIVER FAILURE; AUTOIMMUNE HEPATITIS; CAUSAL ATTRIBUTION; CHRONIC LIVER DISEASE; CLINICAL ASSESSMENT; CLINICAL FEATURE; CLINICAL PRACTICE; COMMON BILE DUCT STONE; CONSENSUS DEVELOPMENT; DIAGNOSTIC ACCURACY; HEALTH CARE PERSONNEL; HEPATITIS B; HEPATITIS C; HUMAN; LIVER BIOPSY; LIVER TOXICITY; MEDICAL SOCIETY; NONALCOHOLIC FATTY LIVER; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RATING SCALE; REPRODUCIBILITY; REVIEW; SCORING SYSTEM; TOXIC HEPATITIS;

EID: 84904887895     PISSN: None     EISSN: 20462484     Source Type: Journal    
DOI: 10.1002/cld.365     Document Type: Review

References (38)

1. Zimmerman HJ. Hepatotoxicity. The adverse effect of drugs and other chemicals on the liver. 2nd edition. Philadelphia, PA: Lippincott Williams & Wilkins; 1999.
2. Temple R. Hy's Law: Predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf 2006;15:241-243.
3. Lewis JH. Drug-induced liver injury throughout the drug development life cycle: where we have been, where we are now, and where we are headed. Perspectives of a clinical hepatologist. Pharmaceutical Med 2013;27:165-91.
4. Standardization of definitions and criteria of causality assessment of adverse drug reactions. Drug-induced liver disorders: report of an international consensus meeting. Int J Clin Pharmacol Ther Toxicol 1990;28:317-322.
5. Danan G, Benichou C. 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 1993;46:1323-1330.
6. Benichou C, Danan G, Flahault A. Causality assessment of adverse reactions to drugs - II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge. J Clin Epidemiol 1993;46:1331-1336.
7. Shapiro MA, Lewis JH. Causality assessment of drug-induced hepatotoxicity: promises and pitfalls. Clinical Liver Disease 2007;11:477-505.
8. Garcia-Cortes M, Lucena MI, Pachkoria K, et al. Evaluation of naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury. Aliment Pharmacol Ther 2008;27:780-789.
9. Teschke R, Frenzel C, Schulze J, Eickoff A. Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods. World J Gastroenterol 2013;19:2864-2882.
10. Garcia-Cortes M, Stephens C, Lucena MI, Fernandez-Castaner A, Andrade RJ, et al. Causality assessment methods in drug induced liver injury: strengths and weaknesses. J Hepatol 2011;55:683-691.
11. Corsini A, Ganey P, Ju C, et al. Current challenges and controversies in drug-induced liver injury. Drug Saf 2012;35:1099-1117.
12. Lucena MI, Garcia-Cortes M, Cueto R, Lopez-Duran J, Andrade RJ. Assessment of drug-induced liver injury in clinical practice. Fundam Clin Pharmacol 2008;22:141-158.
13. Kaplowitz N. Causality assessment versus guilt-by-association in drug hepatotoxicity. Hepatology 2001;33:308-310.
14. Hawkins MT, Lewis JH. Latest advances in predicting DILI in human subjects: focus on biomarkers. Expert Opin Drug Metab Toxicol 2012;8:1521-1530.
15. Schomaker S, Warner R, Bock J, et al. Assessment of emerging biomarkers of liver injury in human subjects. Toxicol Sci 2013;132:276-283.
16. 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;58:777-787.
17. Lucena MI, Camargo R, Andrade RJ, Perez-Sanchez CJ, Sanchez De La Cuesta F. Comparison of two clinical scales for causality assessment in hepatotoxicity. Hepatology 2001;33:123-130.
18. Sgro C, Clinard F, Ouazir K, et al. Incidence of drug-induced injuries: a French population-based study. Hepatology 2002;36:451-455.
19. Lewis JH, Larrey D, Olsson R, Lee WM, Frison L, Keisu M. Utility of the Roussel Uclaf Causality Assessment Method (RUCAM) to analyze the hepatic findings in a clinical trial program: evaluation of the direct thrombin inhibitor ximelagatran. Int J Clin Pharmacol Ther 2008;46:327-339.
20. Rockey DC, Seeff LB, Rochon J, et al. Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel Uclaf Causality Assessment Method. Hepatology 2010;51:2117-2126.
21. Graham DJ, Green L, Senior JR, Nourjah P. Troglitazone-induced liver failure: a case study. Am J Med 2003;114:299-306.
22. Fontana RJ, McCashland TM, Benner KG, et al. Acute liver failure associated with prolonged use of bromfenac leading to liver transplantation. The Acute Liver Failure Study Group. Liver Transpl Surg 1999;5:480-484.
23. Brinker AD, Wassel RT, Lyndly J, et al. Telithromycin-associated hepatotoxicity: clinical spectrum and causality assessment of 42 cases. Hepatology 2009;49:250-257.
24. Robles-Diaz M, Lucena MI, Kaplowitz N, et al. Use of Hy's Law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury. Gastroenterology 2014 (In press).
25. Lewis JH, Kleiner DE. Hepatic injury due to drugs, herbal compounds, chemicals and toxins. In: Burt AD, Portmann BC, Ferrell LD, eds. MacSween's Pathology of the liver. Sixth edition. Edinburgh, UK: Churchill Livingstone; 2012: 645-760.
26. Kleiner DE, Chalasani NP, Lee WM, Fontana RJ, Bonkovsky HL, Drug-Induced Liver Injury Network (DILIN), et al. Hepatic histological findings in suspected drug-induced liver injury: systematic evaluation and clinical associations. Hepatology 2014;59:661-670.
27. Gupta NK, Lewis JH. Review article: the use of potentially hepatotoxic drugs in patients with liver disease. Aliment Pharmacol Ther 2008;28:1021-1041.
28. Lewis JH, Stine JG. Review article: prescribing medications in patients with cirrhosis-a practical guide. Aliment Pharmacol Ther 2013;37:1132-1156.
29. Lammert C, Bjornsson E, Niklasson A, Chalasani N. Oral medications with significant hepatic metabolism at higher risk for hepatic adverse events. Hepatology 2010;51:615-620.
30. 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;58:388-396.
31. Lammert C, Einarsson S, Saha C, Niklasson A, Bjornsson E, Chalasani N. Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury: search for signals. Hepatology 2008;47:2003-2009.
32. Bell LN, Vuppalanchi R, Watkins PB, et al. Serum proteomic profiling in patients with drug-induced liver injury. Aliment Pharmacol Ther 2012;35:600-612.
33. 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:e81974.
34. Daly AK. Pharmacogenomics of adverse drug reactions. Genome Med 2013;5:5.
35. Hoofnagle JH, Serrano J, Knoben JE, Navarro VJ. LiverTox: a website on drug-induced liver injury. Hepatology 2013;57:873-874.
36. Aithal GP. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther 2011;89:806-815.
37. Davern TJ, Chalasani N, Fontana RJ, et al. Acute hepatitis E infection accounts for some cases of suspected drug-induced liver injury. Gastroenterology 2011;141:1665-1672.
38. Watkins PB Managing the risk of drug-induced liver injury. Clin Pharmacol Ther 2013;94:629-631.