medigraphic.com
Órgano Oficial de la Asociación Mexicana de Hepatología

2014, Number 2

<< Back Next >>

Ann Hepatol 2014; 13 (2)

Drug induced liver injury: accuracy of diagnosis in published reports

Teschke R, Frenzel C, Wolff A, Eickhoff A, Schulze J

Language: English
References: 38
Page: 248-255
PDF size: 97.47 Kb.


ABSTRACT

The diagnosis of drug induced liver injury (DILI) is based primarily on the exclusion of alternative causes. To assess the frequency of alternative causes in initially suspected DILI cases, we searched the Medline database with the following terms: drug hepatotoxicity, drug induced liver injury, and hepatotoxic drugs. For each term, we used the first 100 publications. We reviewed references, selected those reports relevant to our study, and retrieved finally 15 publications related to DILI and alternative causes. A total of 2,906 cases of initially assumed DILI were analyzed in these 15 publications, with diagnoses missed in 14% of the cases due to overt alternative causes. In another 11%, the diagnosis of DILI could not be established because of confounding variables. Alternative diagnoses included hepatitis B, C, and E, CMV, EBV, ischemic hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson’s disease, Gilbert’s syndrome, fatty liver, non alcoholic steatohepatitis, alcoholic liver diseases, cardiac and thyroid causes, rhabdomyolysis, polymyositis, postictal state, tumors, lymphomas, chlamydial and HIV infections. Causality assessment methods applied in these 15 publications were the CIOMS (Council for International Organizations of Medical Sciences) scale alone (n = 5) or combined with the Maria and Victorino (MV) scale (n = 1), the DILIN (Drug-Induced Liver Injury Network) method (n = 4), or the Naranjo scale (n = 1); the qualitative CIOMS method alone (n = 3) or combined with the MV scale (n = 1). In conclusion, alternative diagnoses are common in primarily suspected DILI cases and should be excluded early in future cases, requiring a thorough clinical and causality assessment.


REFERENCES

  1. Kaplowitz N, DeLeve LD. Drug-Induced Liver Disease. 3rd. Ed. Mass., USA: Academic Press, Waltham; 2013.

  2. Sistanizad M, Peterson GM. Drug-induced liver injury in the Australian setting. J Clin Pharm Ther 2013; 38: 115-20.

  3. Fontana RJ, Hayashi P, Bonkovsky HL, Kleiner DE, Kochhar S, Gu J, Ghabril M. Presentation and outcomes with clinically apparent interferon beta hepatotoxicity. Dig Dis Sci 2013: 58: 1766-75.

  4. Sembera S, Lammert C, Talwalkar JA, Sanderson SO, Poterucha JJ, Hay JE, Wiesner RH, et al. Frequency, clinical presentation, and outcomes of drug-induced liver injury after liver transplantation. Liver Transpl 2012; 18: 803-10.

  5. Grant LK, Rockey DC. Drug-induced liver injury. Curr Opin Gastroenterol 2012; 28: 198-202.

  6. Chalasani N, Björnsson E. Risk factors for idiosyncratic drug-induced liver injury. Gastroenterology 2010; 138: 2246-59.

  7. Ghabril M, Chalasani N, Björnsson E. Drug-Induced liver injury: a clinical update. Curr Opin Gastroenterol 2010; 26: 222-6.

  8. Hawkins MT, Lewis JH. Latest advances in predicting DILI in human subjects: focus on biomarkers. Expert Opin Drug Metab Toxicol 2012; 8: 1521-30.

  9. Urban TJ, Shen Y, Stolz A, Chalasani N, Fontana RJ, Rochon J, Ge D, et al., Drug-Induced Liver Injury Network, DILIGEN, EUDRAGENE, Spanish DILI Registry, International Serious Adverse Events Consortium. Limited contribution of common genetic variants to risk for liver injury due to a variety of drugs. Pharmacogenet Genomics 2012; 22: 784-95.

  10. Teschke R, Wolff A, Frenzel C, Schulze J, Eickhoff A. Herbal hepatotoxicity: a tabular compilation of reported cases. Liver Int 2012; 32: 1543-56.

  11. Teschke R, Frenzel C, Schulze J, Eickhoff A. Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods. World J Gastroenterol 2013; 19: 2864-82.

  12. Agarwal VK, McHutchison JG, Hoofnagle JH, Drug-Induced Liver Injury Network (DILIN). Important elements for the diagnosis of drug-induced liver injury. Clin Gastroenterol Hepatol 2010; 8: 463-70.

  13. Bénichou 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: 1331-6.

  14. Aithal PG, Day CP. The natural history of histologically proved drug induced liver disease. Gut 1999; 44: 731-5.

  15. Aithal GP, Rawlins MD, Day CP. Accuracy of hepatic adverse drug reaction reporting in one English health region. Br Med J 1999; 319: 154.

  16. Lucena MI, Camargo R, Andrade RJ, Perez-Sanchez CJ, Sanches de la Cuesta F. Comparison of two clinical scales for causality assessment in hepatotoxicity. Hepatology 2001; 33: 123-30.

  17. Sgro C, Clinard F, Ouazir K, Chanay H, Allard C, Guilleminet C, Lenoir C, et al. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology 2002; 36: 451-5.

  18. Andrade RJ, Lucena MI, Fernández MC, Pelaez G, Pachkoria K, García-Ruiz E, García-Muñoz B, et al., Spanish Group for the Study of Drug-induced Liver Disease. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 2005; 129: 512-21.

  19. De Valle MB, Klinteberg V AV, Alem N, Olsson R, Björnsson E. Drug-induced liver injury in a Swedish University hospital out-patient hepatology clinic. Aliment Pharmacol Ther 2006; 24: 1187-95.

  20. Andrade RJ, Lucena MI, Kaplowitz N, García-Muñoz B, Borraz Y, Pachkoria K, García-Cortés M, et al. Outcome of acute idiosyncratic drug-induced liver injury: long term follow-up in a hepatotoxicity registry. Hepatology 2006; 44: 1581-8.

  21. Dalton HR, Fellows HJ, Stableforth W, Joseph M, Thurairajah PH, Warshow U, Hazeldine S, et al. The role of hepatitis E virus testing in drug-induced liver injury. Aliment Pharmacol Ther 2007; 26: 1429-35.

  22. Rochon J, Protiva P, Seeff LB, Fontana RJ, Liangpunsakul S, Watkins PB, Davern T, et al., for the Drug-Induced Liver Injury Network (DILIN). Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury. Hepatology 2008; 48: 1175-83.

  23. García-Cortés M, Lucena MI, Pachkoria K, Borraz Y, Hidalgo R, Andrade RJ. Evaluation of Naranjo Adverse Drug Reactions Probability Scale in causality assessment of drug-induced liver injury. Aliment Pharmacol Ther 2008; 27: 780-9.

  24. Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang HQ, et al., for the Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008; 135: 1924-34.

  25. Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J, for the DILIN Study Group. Drug-induced liver injury Network (DILIN) prospective study. Rationale, design and conduct. Drug Saf 2009; 32: 55-68.

  26. Davern TJ, Chalasani N, Fontana RJ, Hayashi PH, Protiva P, Kleiner DE, Engle RE, et al., for the Drug-Induced Liver Injury Network (DILIN) . Acute hepatitis E infection accounts for some cases of suspected drug-induced liver injury. Gastroenterology 2011; 141: 1665-72.

  27. Björnsson E, Jacobsen EI, Kalaitzakis E. Hepatotoxicity associated with statins: Reports of idiosyncratic liver injury post-marketing. J Hepatol 2012; 56: 374-380.

  28. Danan G, Bénichou 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: 1323-30.

  29. Tajiri K, Shimizu Y. Practical guideline for diagnosis and early management of drug-induced liver injury. World J Gastroenterol 2008; 14: 6774-85.

  30. García-Cortés M, Stephens C, Lucena MI, Fernández- Castañer A, Andrade RJ, on behalf of the Spanish Group for the Study of Drug-Induced Liver Disease. Causality assessment methods in drug induced liver injury: Strengths and weaknesses. J Hepatol 2011; 55: 683-91.

  31. Aithal GP, Watkins PB, Andrade RJ, Larrey D, Molokhia M, Takikawa H, Hunt CM, et al. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther 2011; 89: 806-15.

  32. Bunchorntavakul C, Reddy KR. Review article: herbal and dietary supplement hepatotoxicity. Aliment Pharmacol Ther 2013; 37: 3-17.

  33. Teschke R, Schulze J, Schwarzenboeck A, Eickhoff A, Frenzel C. Herbal hepatotoxicity: suspected cases assessed for alternative causes. Eur J Gastroenterol Hepatol 2013; 25: 1093-8.

  34. Teschke R, Eickhoff A, Schulze J. Drug- and herb-induced liver injury in clinical and translational hepatology: Causality assessment methods, quo vadis? J Clin Translat Hepatol 2013; 1: 59-74.

  35. Bénichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol 1990; 11: 272-6.

  36. Maria VAJ, Victorino RMM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology 1997; 26: 664-9.

  37. Rockey DC, Seeff LB, Rochon J, Freston J, Chalasani N, Bonachini M, Fontana RJ, et al., for the US Drug-induced Liver Injury Network. Causality assessment in drug-induced liver injury using a structured expert opinion process: Comparison to the Roussel-Uclaf causality assessment method. Hepatology 2010; 51: 2117-26.

  38. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239-45.




2020     |     www.medigraphic.com