Causality Assessment Methods in Drug-Induced Liver Injury

Protocol
Part of the Methods in Pharmacology and Toxicology book series (MIPT)

Abstract

A robust causality assessment method (CAM) is not only indispensable for the diagnosis of suspected drug-induced liver injury (DILI) and herb-induced liver injury (HILI) but is also critical for the investigation of the clinical features, risk factors, and incidence in pharmacological or epidemiological studies. RUCAM (Roussel Uclaf Causality Assessment Method) is the most widely used CAM in suspected DILI and HILI cases worldwide, as evidenced by its application in a large number of case reports and case series since RUCAM was first published in 1993. It offers a structured, standardized diagnostic approach specific to liver injury by attributing scores to individual key items that provide final quantitative gradings of causality. In many countries and for more than two decades, physicians, regulatory agencies, case report authors, and pharmaceutical companies have successfully applied this well-validated CAM. The RUCAM update in 2016 clarified a few complicated items such as alcohol use and exclusion of nondrug causes. The intention of this approach was to provide accurately defined and objective core elements to simplify item handling, and therefore reduce interobserver and intraobserver variability. In conclusion, RUCAM should be recommended as the preferred CAM for suspected DILI and HILI cases.

Key words

Drug-induced liver injury DILI Roussel Uclaf Causality Assessment RUCAM Causality assessment methods 

References

  1. 1.
    Sarges P, Steinberg JM, Lewis JH (2016) Drug-induced liver injury: highlights from a review of the 2015 literature. Drug Saf 39:561–575. https://doi.org/10.1007/s4026401604278
  2. 2.
    Chen M, Borlak J, Tong W (2013) High lipophilicity and high daily dose of oral medications are associated with significant risk for drug-induced liver injury. Hepatology 58:388–396PubMedCrossRefGoogle Scholar
  3. 3.
    Chen M, Borlak J, Tong W (2014) Predicting idiosyncratic drug-induced liver injury—some recent advances. Expert Rev Gastroenterol Hepatol 8:721–723. https://doi.org/10.1586/17474124.922871 PubMedCrossRefGoogle Scholar
  4. 4.
    Teschke R, Andrade RJ (2016) Special issue “Drug, Herb, and Dietary Supplement Hepatotoxicity”. Int J Mol Sci. http://www.mdpi.com/journal/ijms/special_issues/Hepatotoxicity. Last Accessed 15 Dec 1016
  5. 5.
    Teschke R, Andrade RJ (2016) Editorial: drug, herb, and dietary supplement hepatotoxicity. Int J Mol Sci 17:1488. https://doi.org/10.3390/ijms17091488 PubMedCentralCrossRefGoogle Scholar
  6. 6.
    Danan G, Teschke R (2016) RUCAM in drug and herb induced liver injury: the update. Int J Mol Sci 17:14. https://doi.org/10.3390/ijms17010014 CrossRefGoogle Scholar
  7. 7.
    Hayashi PH (2016) Drug-induced Liver Injury Network causality assessment: criteria and experience in the United States. Int J Mol Sci 17:201. https://doi.org/10.3390/ijms17020201 PubMedPubMedCentralCrossRefGoogle Scholar
  8. 8.
    Björnsson ES (2016) Hepatotoxicity by drugs: the most common implicated agents. Int J Mol Sci 17:224. https://doi.org/10.3390/ijms17020224 PubMedPubMedCentralCrossRefGoogle Scholar
  9. 9.
    Ortega-Alonso A, Stephens C, Lucena MI, Andrade RJ (2016) Case characterization, clinical features and risk factors in drug-induced liver injury. Int J Mol Sci 17:714. https://doi.org/10.3390/ijms17050714 PubMedCentralCrossRefGoogle Scholar
  10. 10.
    Bessone F, Hernandez N, Lucena MI, Andrade RJ, on behalf of the Latin DILI Network (LATINDILIN) and Spanish DILI Registry (2016) The Latin American DILI registry experience: a successful ongoing collaborative strategic initiative. Int J Mol Sci 17:313. https://doi.org/10.3390/ijms17030313 PubMedPubMedCentralCrossRefGoogle Scholar
  11. 11.
    Frenzel C, Teschke R (2016) Herbal hepatotoxicity: clinical characteristics and listing compilation. Int J Mol Sci 17:588. https://doi.org/10.3390/ijms17050588 PubMedCentralCrossRefGoogle Scholar
  12. 12.
    Valdivia-Correa B, Gómez-Gutiérrez C, Uribe M, Méndez-Sánchez N (2016) Herbal medicine in Mexico: a cause of hepatotoxicity. A critical review. Int J Mol Sci 17:235. https://doi.org/10.3390/ijms17020235 PubMedPubMedCentralCrossRefGoogle Scholar
  13. 13.
    Douros A, Bronder E, Andersohn F, Klimpel A, Kreutz R, Garbe E, Bolbrinker J (2016) Herb-induced liver injury in the Berlin Case-Control Surveillance Study. Int J Mol Sci 17:114. https://doi.org/10.3390/ijms17010114 PubMedCentralCrossRefGoogle Scholar
  14. 14.
    Pantano F, Tittarelli R, Mannocchi G, Zaami S, Ricci S, Giorgetti R, Terranova D, Busardò FP, Marinelli E (2016) Hepatotoxicity induced by “the 3Ks”: Kava, Kratom and Khat. Int J Mol Sci 17:580. https://doi.org/10.3390/ijms17040580 PubMedPubMedCentralCrossRefGoogle Scholar
  15. 15.
    García-Cortés M, Robles-Díaz M, Ortega-Alonso A, Medina-Caliz I, Andrade RJ (2016) Hepatotoxicity by dietary supplements: a tabular listing and clinical characteristics. Int J Mol Sci 17:537. https://doi.org/10.3390/ijms17040537 PubMedPubMedCentralCrossRefGoogle Scholar
  16. 16.
    Teschke R, Eickhoff A (2016) The Honolulu liver disease cluster at the medical center: its mysteries and challenges. Int J Mol Sci 17:476. https://doi.org/10.3390/ijms17040476 PubMedPubMedCentralCrossRefGoogle Scholar
  17. 17.
    Avigan MI, Mozersky RP, Seeff LB (2016) Scientific and regulatory perspectives in herbal and dietary supplement associated hepatotoxicity in the United States. Int J Mol Sci 17:331. https://doi.org/10.3390/ijms17030331 PubMedPubMedCentralCrossRefGoogle Scholar
  18. 18.
    Sgro C, Clinard F, Ouazir K, Chanay H, Allard C, Guilleminet C, Lenoir C, Lemoine A, Hillon P (2002) Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology 36:451–455PubMedCrossRefGoogle Scholar
  19. 19.
    Björnsson ES, Bergmann OM, Björnsson HK, Kvaran RB, Olafsson S (2013) Incidence, presentation and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology 144:1419–1425PubMedCrossRefGoogle Scholar
  20. 20.
    de Abajo FJ, Montero D, Madurga M, García Rodríguez LA (2004) Acute and clinically relevant drug-induced liver injury: population based case–control study. Br J Clin Pharmacol 58:71–80PubMedPubMedCentralCrossRefGoogle Scholar
  21. 21.
    Danan G, Bénichou C (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 46:1323–1330PubMedCrossRefGoogle Scholar
  22. 22.
    Aithal GP, Rawlins MD, Day CP (1999) Accuracy of hepatic adverse drug reactions reported in one English health region. Br Med J 319:1541CrossRefGoogle Scholar
  23. 23.
    Teschke R, Frenzel C, Wolff A, Eickhoff A, Schulze J (2014) Drug induced liver injury: accuracy of diagnosis in published reports. Ann Hepatol 13:248–255PubMedGoogle Scholar
  24. 24.
    Andrade RJ, Lucena MI, Kaplowitz N, García-Muñoz B, Borraz Y, Pachkoria K, García-Cortés M, Fernández MC, Pelaez G, Rodrigo L, Durán JA, Costa J, Planas R, Barriocanal A, Guaner C, Romero-Gomez M, Muņoz-Yagüe T, Salmerón J, Hidalgo R (2006) Outcome of acute idiosyncratic drug-induced liver injury: long term follow-up in a hepatotoxicity registry. Hepatology 44:1581–1588PubMedCrossRefGoogle Scholar
  25. 25.
    Miljkovic MM, Dobric S, Dragojevic-Simic V (2011) Consistency between causality assessments obtained with two scales and their agreement with clinical judgments in hepatotoxicity. Pharmacoepidemiol Drug Saf 20:272–285PubMedCrossRefGoogle Scholar
  26. 26.
    Miljkovic MM, Dobric S, Dragojevic-Simic V (2012) Accuracy and reproducibility of two scales in causality assessment of unexpected hepatotoxicity. J Clin Pharm Ther 37:196–203PubMedCrossRefGoogle Scholar
  27. 27.
    Björnsson E, Jacobsen EI, Kalaitzakis E (2012) Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. J Hepatol 56:374–380. https://doi.org/10.1016/j.jhep.2011.07.023 PubMedCrossRefGoogle Scholar
  28. 28.
    Bénichou C, Danan G, Flahault A (1993) 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 46:1331–1336PubMedCrossRefGoogle Scholar
  29. 29.
    Teschke R, Danan G (2017) Drug-induced liver injury: is chronic liver disease a risk factor and a clinical issue? Expert Opin Drug Metab Toxicol 13:425–438. https://doi.org/10.1080/17425255.2017.1252749 PubMedCrossRefGoogle Scholar
  30. 30.
    Reuben A, Koch DG, Lee WM, the Acute Liver Failure Study Group (2010) Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology 52:2065–2076PubMedPubMedCentralCrossRefGoogle Scholar
  31. 31.
    Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E, Hynan LS, Reisch JS, Schiodt FV, Ostapowicz G, Shakil AO, Lee WM, the Acute Liver Failure Study Group (2005) Acetaminophen-induced acute liver failure: results of a United States multicentre, prospective study. Hepatology 42:1364–1372PubMedCrossRefGoogle Scholar
  32. 32.
    Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, Watkins PB, Navarro V, Barnhart H, Gu J, Serrano J (2015) Features and outcomes of 889 patients with drug-induced liver injury: the DILIN prospective study. Gastroenterology 148:1340–1352. https://doi.org/10.1053/j.gastro.2015.03.006 PubMedPubMedCentralCrossRefGoogle Scholar
  33. 33.
    Maria VAJ, Victorino RMM (1997) Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology 26:664–669PubMedCrossRefGoogle Scholar
  34. 34.
    Takikawa H, Takamori Y, Kumagi T, Onji M, Watanabe M, Shibuya A, Hisamochi A, Kumashiro R, Ito T, Mitsumoto Y, Nakamura A, Sakaguchi T (2003) Assessment of 287 Japanese cases of drug induced liver injury by the diagnostic scale of the International Consensus Meeting. Hepatol Res 27:192–195PubMedCrossRefGoogle Scholar
  35. 35.
    Kaplowitz N (2001) Causality assessment versus guilt-by-association in drug hepatotoxicity. Hepatology 33:308–310PubMedCrossRefGoogle Scholar
  36. 36.
    Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ (1981) A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 30:239–245PubMedCrossRefGoogle Scholar
  37. 37.
    WHO, World Health Organization (2000) The use of the WHO-UMC system for standardised case causality assessment. WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre, UMC), Database 2000. http://who-umc.org/Graphics/24734.pdf Last accessed 15 Dec 2016
  38. 38.
    Teschke R, Frenzel C, Schulze J, Eickhoff A (2013) Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods. World J Gastroenterol 19:2864–2882PubMedPubMedCentralCrossRefGoogle Scholar
  39. 39.
    Bénichou C (1990) Criteria of drug-induced liver disorders. Report of an international Consensus meeting. J Hepatol 11:272–276PubMedCrossRefGoogle Scholar
  40. 40.
    Teschke R, Eickhoff A, Schulze J, Wolff A, Frenzel C, Melchart D (2016) Petadolex®, a herbal extract for migraine prophylaxis with spontaneous case reports of disputed liver injury: robust causality evaluation by RUCAM, the Roussel Uclaf Causality Assessment Method. Eur J Pharmaceut Med Res 3(12):154–177Google Scholar
  41. 41.
    Zimmerman HJ (1999) Hepatotoxicity, 2nd edn. Lippincott Williams & Wilkins, PhiladelphiaGoogle Scholar
  42. 42.
    Yoon E, Babar A, Choudhary M, Kutner M, Pyrsopoulos N (2016) Acetaminophen-induced hepatotoxicity: a comprehensive update. J Clin Translat Hepatol 4:131–142Google Scholar
  43. 43.
    Safari S, Motavaf M, Siamdoust SAS, Alavian SM (2014) Hepatotoxicity of halogenated inhalation anesthetics. Iran Red Crescent Med J 16(9):e20153PubMedPubMedCentralCrossRefGoogle Scholar
  44. 44.
    Gaude GS, Chaudhury A, Hattiholi J (2015) Drug-induced hepatitis and the risk factors for liver injury in pulmonary tuberculosis patients. J Family Med Prim Care 4:238–243. https://doi.org/10.4103/2249-4863.154661 PubMedPubMedCentralCrossRefGoogle Scholar
  45. 45.
    Lee SS, Lee CM, Kim TH, Kim JJ, Lee JM, Kim HJ, Ha CY, Kim HJ, Jung WT, Lee OJ, Kim DY (2016) Frequency and risk factors of drug-induced liver injury during treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis 20:800–805. https://doi.org/10.5588/ijtld.15.0668 PubMedCrossRefGoogle Scholar
  46. 46.
    Agarwal VK, McHutchison JG, Hoofnagle JH, Drug-Induced Liver Injury Network (DILIN) (2010) Important elements for the diagnosis of drug-induced liver injury. Clin Gastroenterol Hepatol 8:463–470PubMedPubMedCentralCrossRefGoogle Scholar
  47. 47.
    Davern TJ, Chalasani N, Fontana RJ, Hayashi PH, Protiva P, Kleiner DE, Engle RE, Nguyen H, Emerson SU, Purcell RH, Tillmann HL, Gu J, Serrano J, Hoofnagle JH, for the Drug-Induced Liver Injury Network (DILIN) (2011) Acute hepatitis E infection accounts for some cases of suspected drug-induced liver injury. Gastroenterology 141:1665–1672. https://doi.org/10.1053/j.gastro.2011.07.051 PubMedPubMedCentralCrossRefGoogle Scholar
  48. 48.
    Hoofnagle JH, Nelson KE, Purcell RH (2012) Review article: hepatitis E. N Engl J Med 367:1237–1244PubMedCrossRefGoogle Scholar
  49. 49.
    Teschke R, Schulze J, Eickhoff A, Wolff A, Frenzel C (2015) Review article: mysterious hawaii liver disease case—naproxen overdose as cause rather than OxyELITE Pro? J Liver Clin Res 2:1013. http://www.jscimedcentral.com/Liver/liver-2-1013.pdf. Last accessed 15 Dec 2016Google Scholar
  50. 50.
    Teschke R, Schwarzenboeck A, Frenzel C, Schulze J, Eickhoff A, Wolff A (2016) The mystery of the Hawaii liver disease cluster in summer 2013: a pragmatic and clinical approach to solve the problem. Ann Hepatol 15:91–119. http://www.annalsofhepatology.com.mx/revista/numeros/2016/HP161-12-Mystery%20(web)%20(FF_041215V)_PROTEGIDO%20(1).pdf. Last accessed 15 Dec 2016PubMedCrossRefGoogle Scholar
  51. 51.
    Teschke R, Eickhoff A (2017) Suspected liver injury and the dilemma of causality. Dig Dis Sci 62:1095–1098. https://doi.org/10.1007/s10620-016-4442-5 PubMedCrossRefGoogle Scholar
  52. 52.
    Hennes EM, Zeniya M, Czaja AJ, Parés A, Dalekos GN, Krawitt EL, Bittencourt PL, Porta G, Boberg KM, Hofer H, Bianchi FB, Shibata M, Schramm C, Eisenmann de Torres B, Galle PR, McFarlane I, Dienes HP, Lohse AW, International Autoimmune Hepatitis Group (2008) Simplified criteria for the diagnosis of autoimmune hepatitis. Hepatology 48:169–176PubMedCrossRefGoogle Scholar
  53. 53.
    National Institutes of Health (NIH) and LiverTox (2016) Agents included in LiverTox by drug class. Last updated 6 Sep 2016. http://livertox.nlm.nih.gov/index.html. Last accessed 15 Dec 2016
  54. 54.
    Teschke R, Frenzel C (2014) Drug induced liver injury: do we still need a routine liver biopsy for diagnosis today? Ann Hepatol 13:121–126Google Scholar
  55. 55.
    Teschke R, Eickhoff A, Schwarzenboeck A, Schmidt-Taenzer W, Genthner A, Frenzel C, Wolff A, Schulze J (2015) Clinical review: herbal hepatotoxicity and the call for systematic data documentation of individual cases. J Liver Clin Res 2(1):1008. http://www.jscimedcentral.com/Liver/liver-2-1008.pdf. Last accessed 15 December 2016Google Scholar
  56. 56.
    Teschke R, Danan G (2016) Diagnosis and management of drug-induced liver injury (DILI) in patients with pre-existing liver disease. Drug Saf 39:729–744. https://doi.org/10.1007/s40264-016-0423-z PubMedCrossRefGoogle Scholar
  57. 57.
    Andrade RJ, Lucena MI, Fernández MC, Pelaez G, Pachkoria K, García-Ruiz E, García-Muñoz B, Gonzalez-Grande R, Pizarro A, Durán JA, Jiménez M, Rodrigo L, Romero-Gomez M, Navarro JM, Planas R, Costa J, Borras A, Soler A, Salmerón J, Martin-Vivaldi R, Spanish Group for the Study of Drug-induced Liver Disease (2005) Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 129:512–521PubMedCrossRefGoogle Scholar
  58. 58.
    Wai CT (2016) Presentation of drug-induced liver injury in Singapore. Singapore Med J 47:116–120Google Scholar
  59. 59.
    Björnsson E, Olsson R (2007) Serious adverse liver reactions associated with herbal weight loss supplements. J Hepatol 47:295–297PubMedCrossRefGoogle Scholar
  60. 60.
    EMA (European Medicine Agency) (2007) Assessment of case reports connected to herbal medicinal products containing cimicifugae racemosae rhizoma (black cohosh, root). Issued 8 May 2007. http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_HMPC_assessment_report/2010/02/WC500074167.pdf. Last accessed 15 Dec 2016
  61. 61.
    García-Cortés M, Borraz Y, Lucena MI, Peláez G, Salmerón J, Diago M, Martínez-Sierra MC, Navarro JM, Planas R, Soria MJ, Bruguera M, Andrade RJ (2008) Liver injury induced by “natural remedies”: an analysis of cases submitted to the Spanish Liver Toxicity Registry. Rev Esp Enferm Dig 100:688–695PubMedCrossRefGoogle Scholar
  62. 62.
    García-Cortés M, Lucena MI, Pachkoria K, Borraz Y, Hidalgo R, Andrade RJ (2008) Evaluation of Naranjo Adverse Drug Reactions Probability Scale in causality assessment of drug-induced liver injury. Aliment Pharmacol Ther 27:780–789PubMedCrossRefGoogle Scholar
  63. 63.
    Daly AK, Donaldson PT, Bhatnagar P, Shen Y, Pe'er I, Floratos A, Daly MJ, Goldstein DB, John S, Nelson MR, Graham J, Park BK, Dillon JF, Bernal W, Cordell HJ, Pirmohamed M, Aithal GP, Day CP, for the DILIGEN Study & International SAE Consortium (2009) HLA-B*5701 genotype is a major determinant of drug-induced liver injury due to flucloxacillin. Nat Genet 41:816–819PubMedCrossRefGoogle Scholar
  64. 64.
    Jung KA, Min HJ, Yoo SS, Kim HJ, Choi SN, Ha CY, Kim HJ, Kim TH, Jung WT, Lee OJ, Lee JS, Shim SG (2011) Drug-induced liver injury: twenty five cases of acute hepatitis following ingestion of Polygonum multiflorum Thun. Gut Liver 5:493–499PubMedPubMedCentralCrossRefGoogle Scholar
  65. 65.
    Chau TN, Cheung WI, Ngan T, Lin J, Lee KWS, Poon WT, Leung VKS, Mak T, Tse ML, the Hong Kong Herb-Induced Liver Injury Network (HK-HILIN) (2011) Causality assessment of herb-induced liver injury using multidisciplinary approach and the Roussel Uclaf Causality assessment Method (RUCAM). Clin Toxicol 49:34–39CrossRefGoogle Scholar
  66. 66.
    Lucena MI, Molokhia M, Shen Y, Urban TJ, Aithal GP, Andrade RJ, Day CP, Ruiz-Cabello F, Donaldson PT, Stephens C, Pirmohamed M, Romero-Gomez M, Navarro JM, Fontana RJ, Miller M, Groome M, Bondon-Guitton E, Conforti A, Stricker BHC, Carvajal A, Ibanez L, Yue QY, Eichelbaum M, Floratos A, Pe’er I, Daly MJ, Goldstein DB, Dillon JF, Nelson MR, Watkins PB, Daly AK, Spanish DILI Registry, EUDRAGENE, DILIN, DILIGEN, and International SAEC (2011) Susceptibility to amoxicillin-clavulanate-induced liver injury is influenced by multiple HLA class I and II alleles. Gastroenterology 141:338–347PubMedPubMedCentralCrossRefGoogle Scholar
  67. 67.
    Stammschulte T, Treichel U, Pachl H, Gundert-Remy U (2016) Cases of liver failure in association with flupirtine in the German spontaneous reporting system. http://www.akdae.de/Kommission/Organisation/Aufgaben/Publikationen/PDF/Stammschulte2012.pdf. Last accessed 15 Dec 2016
  68. 68.
    Douros A, Bronder E, Andersohn F, Klimpel A, Thomae M, Orzechowski HD, Kreutz R, Garbe E (2014) Flupirtine-induced liver injury—seven cases from the Berlin Case–Control Surveillance Study and review of the German spontaneous adverse drug reaction reporting database. Eur J Clin Pharmacol 70:453–459PubMedCrossRefGoogle Scholar
  69. 69.
    Robles-Diaz M, Gonzalez-Jimenez A, Medina-Caliz I, Stephens C, García-Cortes M, García-Muñoz B, Ortega-Alonso A, Blanco-Reina E, Gonzalez-Grande R, Jimenez-Perez M, Rendón P, Navarro JM, Gines P, Prieto M, Garcia-Eliz M, Bessone F, Brahm JR, Paraná R, Lucena MI, Andrade RJ, on behalf of the Spanish DILI Registry and the SLatinDILI Network (2015) Distinct phenotype of hepatotoxicity associated with illicit use of anabolic androgenic steroids. Aliment Pharmacol Ther 41:116–125PubMedCrossRefGoogle Scholar
  70. 70.
    Douros A, Bronder E, Andersohn F, Klimpel A, Thomae M, Sarganas G, Kreutz R, Garbe E (2015) Drug-induced liver injury: results from the hospital-based Berlin Case–Control Surveillance Study. Br J Clin Pharmacol 79:988–999. https://doi.org/10.1111/bcp.12565 PubMedPubMedCentralCrossRefGoogle Scholar
  71. 71.
    Flamenbaum M, Abergel A, Marcato N, Zénut KJL, Cassan P (1998) Regressive fulminant hepatitis, acute pancreatitis and renal insufficiency after taking ketoprofen. Gastroenterol Clin Biol 22:975PubMedGoogle Scholar
  72. 72.
    Lucena MI, Carvajal A, Andrade RJ, Velasco A (2003) Antidepressant-induced hepatotoxicity. Expert Opinion Drug Saf 2:249–262CrossRefGoogle Scholar
  73. 73.
    Stickel F, Baumüller HM, Seitz K, Vasilakis D, Seitz G, Seitz HK, Schuppan D (2003) Hepatitis induced by Kava (Piper methysticum rhizoma). J Hepatol 39:62–67PubMedCrossRefGoogle Scholar
  74. 74.
    Masumoto T, Horiike N, Abe M, Kumaki T, Matsubara H, Fazle Akbar SM, Michitaka K, Hyodo I, Onji M (2003) Diagnosis of drug-induced liver injury in Japanese patients by criteria of the Consensus Meetings in Europe. Hepatol Res 25:1–7PubMedCrossRefGoogle Scholar
  75. 75.
    Andrade RJ, Lucena MI, Alonso A, García-Cortés M, García-Ruiz E, Benitez R, Fernández MC, Pelaez G, Romero M, Corpas R, Durán JA, Jiménez M, Rodrigo L, Nogueras F, Martín-Vivaldi R, Navarro JM, Salmerón J, Sánchez de la Cuesta F, Hidalgo R (2004) HLA class II genotype influences the type of liver injury in drug-induced idiosyncratic liver disease. Hepatology 39:1603–1612PubMedCrossRefGoogle Scholar
  76. 76.
    Arotcarena R, Bigué JP, Etcharry F, Pariente A (2004) Pioglitazone-induced acute severe hepatitis. Gastroenterol Clin Biol 28:609–618. Abstract in English, article in FrenchCrossRefGoogle Scholar
  77. 77.
    Lee WM, Larrey D, Olsson R, Lewis JH, Keisu M, Auclert L, Sheth S (2005) Hepatic findings in long-term clinical trials of ximelagatran. Drug Saf 28:351–370PubMedCrossRefGoogle Scholar
  78. 78.
    Jorge OA, Jorge AD (2005) Hepatotoxicity associated with the ingestion of Centella asiatica. Rev Esp Enferm Dig 97:115–124PubMedCrossRefGoogle Scholar
  79. 79.
    Gloro R, Hourmand-Ollivier I, Mosquet B, Mosquet L, Rousselot P, Salamé E, Piquet MA, Dao T (2005) Fulminant hepatitis during self-medication with hydroalcoholic extract of green tea. Eur J Gastroenterol Hepatol 17:1135–1137PubMedCrossRefGoogle Scholar
  80. 80.
    Fontana RJ, Shakil O, Greenson JK, Boyd I, Lee WM (2005) Acute liver failure due to amoxicillin and amoxicillin/clavulanate. Dig Dis Sci 50(10):1785–1790PubMedCrossRefGoogle Scholar
  81. 81.
    De Valle MB, Av Klinteberg V, Alem N, Olsson R, Björnsson E (2006) Drug-induced liver injury in a Swedish University hospital out-patient hepatology clinic. Aliment Pharmacol Ther 24:1187–1195PubMedCrossRefGoogle Scholar
  82. 82.
    Yuen MF, Tam S, Fung J, Wong DKH, Wong BCY, Lai CL (2006) Traditional Chinese Medicine causing hepatotoxicity in patients with chronic hepatitis B infection: a 1-year prospective study. Aliment Pharmacol Ther 24:1179–1186PubMedCrossRefGoogle Scholar
  83. 83.
    Jimenez-Saenz M, Martinez-Sanchez Mdel C (2006) Acute hepatitis associated with the use of green tea infusions. J Hepatol 44:616–617PubMedCrossRefGoogle Scholar
  84. 84.
    Cárdenas A, Restrepo JC, Sierra F, Correa G (2006) Acute hepatitis due to shen-min: a herbal product derived from Polygonum multiflorum. J Clin Gastroenterol 40:629–632PubMedCrossRefGoogle Scholar
  85. 85.
    Yan B, Leung Y, Urbanski SJ, Myers RP (2006) Rofecoxib-induced hepatotoxicity: a forgotten complication of the coxibs. Can J Gastroenterol 20:351–355PubMedPubMedCentralCrossRefGoogle Scholar
  86. 86.
    Hussaini SH, O’Brien CS, Despott EJ, Dalton HR (2007) Antibiotic therapy: a major cause of drug-induced jaundice in southwest England. Eur J Gastroenterol Hepatol 19:15–20PubMedCrossRefGoogle Scholar
  87. 87.
    Stojanovski SD, Casavant MJ, Mousa HM, Baker P, Nahata MC (2007) Atomoxetine-induced hepatitis in a child. Clin Tox 45:51–55CrossRefGoogle Scholar
  88. 88.
    Björnsson E, Kalaitzakis E, Klinteberg VAV, Alem E, Olsson R (2007) Long-term follow-up of patients with mild to moderate drug-induced liver injury. Aliment Pharmacol 26:79–85CrossRefGoogle Scholar
  89. 89.
    Rigato I, Cravatari M, Avellini C, Ponte E, Crocè SL, Tiribelli C (2007) Drug-induced acute cholestatic liver damage in a patient with mutation of UGT1A1. Nat Clin Pract Gastroenterol Hepatol 4:403–408PubMedCrossRefGoogle Scholar
  90. 90.
    Teschke R, Schwarzenboeck A, Hennermann KH (2008) Kava hepatotoxicity: a clinical survey and critical analysis of 26 suspected cases. Eur J Gastroenterol Hepatol 20:1182–1193PubMedCrossRefGoogle Scholar
  91. 91.
    Kang SH, Kim JI, Jeong KH, Ko KH, Ko PG, Hwang SW, Kim EM, Kim SH, Lee HY, Lee BS (2008) Clinical characteristics of 159 cases of acute toxic hepatitis. Korean J Hepatol 14:483–492. Abstract in English, article in KoreanPubMedCrossRefGoogle Scholar
  92. 92.
    Sohn CH, Cha MI, Oh BJ, Yeo WH, Lee JH, Kim W, Lim KS (2008) Liver transplantation for acute toxic hepatitis due to herbal medicines and preparations. J Korean Soc Clin Toxicol 6:110–116. Abstract in English, article in KoreanGoogle Scholar
  93. 93.
    Choi GY, Yang HW, Cho SH, Kang DW, Go H, Lee WC, Lee YJ, Jung SH, Kim AN, Cha SW (2008) Drug-induced hepatitis caused by albendazole. J Korean Med Sci 23:903–905PubMedPubMedCentralCrossRefGoogle Scholar
  94. 94.
    Teschke R, Bahre R (2009) Severe hepatotoxicity by Indian Ayurvedic herbal products: a structured causality assessment. Ann Hepatol 8:258–266PubMedGoogle Scholar
  95. 95.
    Mazzanti G, Menniti-Ippolito F, Moro PA, Cassetti F, Raschetti R, Santuccio C, Mastrangelo S (2009) Hepatotoxicity from green tea: a review of the literature and two unpublished cases. Eur J Clin Pharmacol 65:331–341PubMedCrossRefGoogle Scholar
  96. 96.
    Stickel F, Droz S, Patsenker E, Bögli-Stuber K, Aebi B, Leib SL (2009) Severe hepatotoxicity following ingestion of Herbalife nutritionally supplements contaminated with Bacillus subtilis. J Hepatol 50:111–117PubMedCrossRefGoogle Scholar
  97. 97.
    Kang HS, Choi HS, Yun TJ, Lee KG, Seo YS, Yeon JE, Byun KS, Um SH, Kim CD, Ryu HS (2009) A case of acute cholestatic hepatitis induced by Corydalis speciosa Max. Korean J Hepatol 15:517–523. Abstract in English, article in KoreanPubMedCrossRefGoogle Scholar
  98. 98.
    Teschke R, Schwarzenboeck A (2009) Suspected hepatotoxicity by cimicifugae racemosae rhizoma (black cohosh, root): critical analysis and structured causality assessment. Phytomedicine 16:72–84PubMedCrossRefGoogle Scholar
  99. 99.
    Teschke R, Bahre R, Fuchs J, Wolff A (2009) Black cohosh hepatotoxicity: quantitative causality evaluation in nine suspected cases. Menopause 16:956–965PubMedCrossRefGoogle Scholar
  100. 100.
    Kim SY, Yim HJ, Ahn JH, Kim JH, Kim JN, Yoon I, Kim DI, Lee HS, Lee SW, Choi JH (2009) Two cases of toxic hepatitis caused by arrowroot juice. Korean J Hepatol 15:504–509. Abstract in English, article in KoreanPubMedCrossRefGoogle Scholar
  101. 101.
    Harugeri A, Parthasarathi G, Sharma J, D’Souza GA, Ramesh M (2009) Montelukast induced acute hepatocellular injury. J Postgrad Med 55:141–142PubMedCrossRefGoogle Scholar
  102. 102.
    Licata A, Calvaruso V, Capello M, Craxi A, Almasio PL (2010) Clinical course and outcomes of drug-induced liver injury: nimesulide as the first implicated medication. Dig Liver Dis 42:143–148PubMedCrossRefGoogle Scholar
  103. 103.
    Essaid A, Timraz A (2010) Cholestatic acute hepatitis induced by tadalafil (Cialis®). Gastroenterol Clin Biol 34:e1–e2. Abstract in English, article in FrenchPubMedCrossRefGoogle Scholar
  104. 104.
    Jóhannsson M, Ormarsdóttir S, Olafsson S (2010) Hepatotoxicity associated with the use of Herbalife. Laeknabladid 96:167–172PubMedGoogle Scholar
  105. 105.
    Bae SH, Kim DH, Bae YS, Lee KJ, Kim DW, Yoon JB, Hong JH, Kim SH (2010) Toxic hepatitis associated with Polygoni multiflori. Korean J Hepatol 16:182–186. Abstract in English, article in KoreanPubMedCrossRefGoogle Scholar
  106. 106.
    Treeprasertsuk S, Huntrakul J, Ridtitid W, Kullavanijaya P, Björnsson ES (2010) The predictors of complications in patients with drug-induced liver injury caused by antimicrobial agents. Aliment Pharmacol Ther 11:1200–1207CrossRefGoogle Scholar
  107. 107.
    Yang HN, Kim DJ, Kim YM, Kim BH, Sohn KM, Choi MJ, Choi YH (2010) Aloe-induced toxic hepatitis. J Korean Med Sci 25:492–495PubMedPubMedCentralCrossRefGoogle Scholar
  108. 108.
    Singla A, Hammad HT, Hammoud GM (2010) Uncommon cause of acute drug-induced liver injury following mammoplasty. Gastroenterol Res 3:171–172Google Scholar
  109. 109.
    Teschke R (2010) Kava hepatotoxicity: a clinical review. Ann Hepatol 9:251–265PubMedGoogle Scholar
  110. 110.
    Lin G, Wang JY, Li N, Li M, Gao H, Ji Y, Zhang F, Wang H, Zhou Y, Ye Y, Xu HX, Zheng J (2011) Hepatic sinusoidal obstruction syndrome associated with consumption of Gynura segetum. J Hepatol 54:666–673PubMedCrossRefGoogle Scholar
  111. 111.
    Gluck N, Fried M, Porat R (2011) Acute amiodarone liver toxicity likely due to ischemic hepatitis. Isr Med Ass J 13:748–752Google Scholar
  112. 112.
    Sabaté M, Ibáñez L, Pérez E, Vidal X, Buti M, Xiol X, Mas A, Guarner C, Forné M, Solà R, Castellote J, Rigau J, Laporte JR (2011) Paracetamol in therapeutic dosages and acute liver injury: causality assessment in a prospective case series. BMC Gastroenterol 11:80. http://www.biomedcentral.com/1471-230X/11/80. Last accessed 15 December 2016PubMedPubMedCentralCrossRefGoogle Scholar
  113. 113.
    Teschke R, Glass X, Schulze J (2011) Herbal hepatotoxicity by Greater Celandine (Chelidonium majus): causality assessment of 22 spontaneous reports. Regul Toxicol Pharmacol 61:282–291PubMedCrossRefGoogle Scholar
  114. 114.
    Teschke R, Schmidt-Taenzer W, Wolff A (2011) Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: is the liver unspecific Naranjo scale precise enough to ascertain causality? Pharmacoepidemiol Drug Saf 20:567–582PubMedCrossRefGoogle Scholar
  115. 115.
    Teschke R, Frenzel C, Schulze J, Eickhoff A (2012) Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: was causality adequately ascertained? Regul Toxicol Pharmacol 63:1–9PubMedCrossRefGoogle Scholar
  116. 116.
    Timcheh-Hariri A, Balali-Mood M, Aryan E, Sadeghi M, Riahi-Zanjani B (2012) Toxic hepatitis in a group of 20 male body-builders taking dietary supplements. Food Chem Toxicol 50:3826–3832PubMedCrossRefGoogle Scholar
  117. 117.
    Teschke R, Frenzel C, Glass X, Schulze J, Eickhoff A (2012) Greater Celandine hepatotoxicity: a clinical review. Ann Hepatol 11:838–848PubMedGoogle Scholar
  118. 118.
    Moch C, Rocher F, Lainé P, Lacotte J, Biour M, Gouraud A, Bernard N, Descotes J, Vial T (2012) Etifoxine-induced acute hepatitis: a case series. Clin Res Gastroenterol Hepatol 36:e85–e88CrossRefGoogle Scholar
  119. 119.
    Kim YJ, Ryu SL, Shim JW, Kim DS, Shim JY, Park MS, Jung HL (2012) A pediatric case of toxic hepatitis induced by Hovenia dulcis. Pediatr Gastroenterol Hepatol Nutr 15:111–116CrossRefGoogle Scholar
  120. 120.
    Gao H, Li N, Wang JY, Zhang SC, Lin G (2012) Definitive diagnosis of hepatic sinusoidal obstruction syndrome induced by pyrrolizidine alkaloids. J Dig Dis 13:33–39PubMedCrossRefGoogle Scholar
  121. 121.
    Sprague D, Bamha K (2012) Drug-induced liver injury due to varenicline. BMC Gastroenterol 12:65PubMedPubMedCentralCrossRefGoogle Scholar
  122. 122.
    Suk KT, Kim DJ, Kim CH, Park SH, Yoon JH, Kim YS, Baik GH, Kim JB, Kweon YO, Kim BI, Kim SH, Kim IH, Kim JH, Nam SW, Paik YH, Suh JI, Sohn JH, Ahn BM, Um SH, Lee HJ, Cho M, Jang MK, Choi SK, Hwang SG, Sung HT, Choi JY, Han KH (2012) A prospective nationwide study of drug-induced liver injury in Korea. Am J Gastroenterol 107:1380–1387PubMedCrossRefGoogle Scholar
  123. 123.
    Hou FQ, Zeng Z, Wang GQ (2012) Hospital admissions for drug-induced liver injury: clinical features, therapy, and outcomes. Cell Biochem Biophys 64:77–83PubMedCrossRefGoogle Scholar
  124. 124.
    Nabha L, Balba GP, Tuanzon C, Kumar PN (2012) Etravirine induced severe hpersensitivity reaction and fulminant hepatitis: a case report and review of the literature. J AIDS Clin Res S2:005. https://doi.org/10.4172/2155-6113.S2-005 Google Scholar
  125. 125.
    Teschke R, Frenzel C, Wolff A, Herzog J, Glass X, Schulze J, Eickhoff A (2012) Initially purported hepatotoxicity by Pelargonium sidoides: the dilemma of pharmacovigilance and proposals for improvements. Ann Hepatol 11:500–512PubMedGoogle Scholar
  126. 126.
    Ripault MP, Pinzani V, Fayolle V, Pageaux GP, Larrey D (2013) Crizotinib-induced acute hepatitis: first case with relapse after reintroduction with reduced dose. Clin Res Gastroenterol Hepatol 37:e21–e23CrossRefGoogle Scholar
  127. 127.
    Carrier P, Godet B, Crepin S, Magy L, Debette-Gratien M, Pillegand B, Jacques J, Sautereau D, Vidal E, Labrousse F, Gondran G, Loustaud-Ratti V (2013) Acute liver toxicity due to methylprednisolone: consider this diagnosis in the context of autoimmunity. Clin Res Gastroenterol Hepatol 37:100–104CrossRefGoogle Scholar
  128. 128.
    Ríos D, Restrepo JC (2013) Abendazole-induced liver injury: a case report. Colombia Méd 44:118–120Google Scholar
  129. 129.
    Teschke R, Frenzel C, Schulze J, Schwarzenboeck A, Eickhoff A (2013) Herbalife hepatotoxicity: evaluation of cases with positive reexposure tests. World J Hepatol 5:353–363PubMedPubMedCentralCrossRefGoogle Scholar
  130. 130.
    Goossens N, Spahr L, Rubbia-Brandt L (2013) Severe immune-mediated drug-induced liver injury linked to ibandronate: a case report. J Hepatol 59:1139–1142PubMedCrossRefGoogle Scholar
  131. 131.
    Markova SM, De Marco T, Bendjilali N, Kobashigawa EA, Mefford J, Sodhi J, Le H, Zhang C, Halladay J, Rettie AE, Khojasteh C, McGlothlin D, AHB W, Hsueh WC, Witte JS, Schwartz JB, Kroetz DL (2013) Association of CYP2C9*2 with bosentan-induced liver injury. Clin Pharmacol Ther 94:678–686PubMedCrossRefGoogle Scholar
  132. 132.
    Abenavoli L, Milic N, Beaugrand M (2013) Severe hepatitis by cyproterone acetate: role of corticosteroids. A case report. Ann Hepatol 12:152–155PubMedGoogle Scholar
  133. 133.
    Marumoto A, Roytman MM, Tsai NCS (2013) Trial and error: investigational drug induced liver injury, a case series report. Hawaii J Med Publ Health 72(Suppl 4):30–33Google Scholar
  134. 134.
    Adnan MM, Khan M, Hashmi S, Hamza M, AbdulMujeeb S, Amer S (2014) Black cohosh and liver toxicity: is there a relationship? Case Rep Gastrointest Med 2014:860614. https://doi.org/10.1155/2014/860614 Google Scholar
  135. 135.
    Lin J, Moore D, Hockey B, Di Lernia R, Gorelik A, Liew D, Nicoll A (2014) Drug-induced hepatotoxicity: incidence of abnormal liver function tests consistent with volatile anaesthetic hepatitis in traumatic patients. Liver Int 34:576–586PubMedCrossRefGoogle Scholar
  136. 136.
    Cheetham TC, Lee J, Hunt CM, Niu F, Reisinger S, Murray R, Powell G, Papay J (2014) An automated causality assessment algorithm to detect drug-induced liver injury in electronic medical record data. Pharmacoepidemiol Drug Saf 23:601–608PubMedCrossRefGoogle Scholar
  137. 137.
    Russmann S, Niedrig DF, Budmiger M, Schmidt C, Stieger B, Hürlimann S, Kullak-Ublick GA (2014) Rivaroxaban postmarketing risk of liver injury. J Hepatol 61:293–300PubMedCrossRefGoogle Scholar
  138. 138.
    Bohm N, Bohm N, Makowski C, Machado M, Davie A, Seabrook N, Wheless L, Bevill B, Clark B, Kyle TR III (2014) Case report and cohort analysis of drug-induced liver injury associated with daptomycin. Antimicrob Agents Chemother 58:4902–4903PubMedPubMedCentralCrossRefGoogle Scholar
  139. 139.
    Saiful-Islam M, Wright G, Tanner P, Lucas R (2014) A case of anastrazole-related drug-induced autoimmune hepatitis. Clin J Gastroenterol 7:414–417CrossRefGoogle Scholar
  140. 140.
    Im SG, Yoo SH, Jeon DO, Cho HJ, Choi JY, Paik S, Park YM (2014) Chelidonium majus-induced acute hepatitis. Ewha Med J 37:60–63CrossRefGoogle Scholar
  141. 141.
    Lim R, Choundry H, Conner K, Karnsakul W (2014) A challenge for diagnosing acute liver injury with concomitant/sequential exposure to multiple drugs: can causality assessment scales be utilized to identify the offending drug? Case Rep Pediatr 2014:156389PubMedPubMedCentralGoogle Scholar
  142. 142.
    Hao K, Yu Y, He C, Wang M, Wang S, Li X (2014) RUCAM scale-based diagnosis, clinical features and prognosis of 140 cases of drug-induced liver injury. Zhonghua gan zang bing za zhi 22: 938-941. Abstract in English, article in ChineseGoogle Scholar
  143. 143.
    Veluswamy RR, Ward SC, Yum K, Abramovitz RB, Isola LM, Jagannath S, Parekh S (2014) Adverse drug reaction: pomalidomide-induced liver injury. Lancet 383:2125–2126PubMedCrossRefGoogle Scholar
  144. 144.
    Teschke R, Zhang L, Melzer L, Schulze J, Eickhoff A (2014) Green tea extract and the risk of drug-induced liver injury. Expert Opin Drug Metab Toxicol 10:1663–1676. https://doi.org/10.1517/17425255.2014.971011 PubMedCrossRefGoogle Scholar
  145. 145.
    Pillukat MH, Bester C, Hensel A, Lechtenberg M, Petereit F, Beckebaum S, Müller KM, Schmidt HHJ (2014) Concentrated green tea extract induces severe acute hepatitis in a 63-year-old woman—a case report with pharmaceutical analyis. J Ethnopharmacol 155:165–170. https://doi.org/10.1016/j.jep.2014.05.015 PubMedCrossRefGoogle Scholar
  146. 146.
    Lee WJ, Kim HW, Son CG (2015) Systematic review on herb induced liver injury in Korea. Food Chem Toxicol 84:47–54. https://doi.org/10.1016/j.fct.2015.06.004 PubMedCrossRefGoogle Scholar
  147. 147.
    Yilmaz B, Yilmaz B, Aktaş B, Unlu O, Roach EC (2015) Lesser celandine (pilewort) induced acute toxic liver injury: the first case report worldwide. World J Hepatol 7:285–288PubMedPubMedCentralCrossRefGoogle Scholar
  148. 148.
    Mazzanti G, Di Soto A, Vitalone A (2015) Hepatotoxicity of green tea: an update. Arch Toxicol 89:1175–1191PubMedCrossRefGoogle Scholar
  149. 149.
    Tauqeer A, Pandey R, Shah R, Black J (2015) Resolution of ipilimumab induced severe hepatotoxicity with triple immunosuppressants therapy. BMJ Case Rep. https://doi.org/10.1136/bcr-2014-208102. Last accessed 15 Dec 2016
  150. 150.
    Son CG (2015) Drug-induced liver injury by Western medication. J Int Korean Med 36:69–75CrossRefGoogle Scholar
  151. 151.
    Baig M, Wool KJ, Halalnych JH, Sarmad RA (2015) Acute liver failure after initiation of rivaroxaban: a case report and review of the literature. N Am J Med Sci 7:407–410PubMedPubMedCentralCrossRefGoogle Scholar
  152. 152.
    Tang DM, Koh C, Twaddell WS, von Rosenvinge EC, Han H (2015) Acute hepatocellular drug-induced liver injury from bupropion and doxycycline. ACG Case Rep J 3:66–68PubMedPubMedCentralCrossRefGoogle Scholar
  153. 153.
    Zambrone FAD, Corrêa CL, Sampaio do Amaral LM (2015) A critical analysis of the hepatotoxicity cases described in the literature related to Herbalife products. Braz J Pharm Sci 51. https://doi.org/10.1590/S1984-82502015000400004
  154. 154.
    Woo HJ, Kim HY, Choi ES, Cho Y, Kim Y, Lee JH, Jang E (2015) Drug-induced liver injury: a 2-year retrospective study of 1169 hospitalized patients in a single medical center. Phytomedicine 13:1201–1205. http://www.sciencedirect.com/science/article/pii/S0944711315003049 CrossRefGoogle Scholar
  155. 155.
    Wang J, Ma Z, Niu M, Zhu Y, Liang Q, Zhao Y, Song J, Bai Z, Zhang Y, Zhang P, Li N, Meng Y, Li Q, Qin L, Teng G, Cao J, Li B, Chen S, Li Y, Zou Z, Zhou H, Xiao X (2015) Evidence chain-based causality identification in herb-induced liver injury: exemplification of a well-known liver-restorative herb Polygonum multiflorum. Front Med 9:457–467. https://doi.org/10.1007/s11684-015-0417-8 PubMedCrossRefGoogle Scholar
  156. 156.
    Zhu Y, Li YG, Wang JB, Liu SH, Wang LF, Zhao YL, Bai YF, Wang ZX, Li JY, Xiao XH (2015) Causes, features, and outcomes of drug-induced liver injury in 69 children from China. Gut Liver 9:525–533. https://doi.org/10.5009/gnl14184 PubMedPubMedCentralCrossRefGoogle Scholar
  157. 157.
    Zhu Y, Liu SH, Wang JB, Song HB, Li YG, He TT, Ma X, Wang ZX, Wang LP, Zhou K, Bai YF, Zou ZS, Xiao XH (2015) Clinical analysis of drug-induced liver injury caused by Polygonum multiflorum and its preparations. Zhongguo Zhong Xi Yi Jie He Za Zhi 35:1442–1447. (Abstract in English, article in Chinese)PubMedGoogle Scholar
  158. 158.
    Zhu Y, Niu M, Chen J, Zou ZS, Ma ZJ, Liu SH, Wang RL, He TT, Song HB, Wang ZX, SB P, Ma X, Wang LF, Bai ZF, Zhao YL, Li YG, Wang JB, Xiao XB (2016) Comparison between Chinese herbal medicine and Western medicine-induced liver injury of 1985 patients. J Gastroenterol Hepatol 31:1476–1482. https://doi.org/10.1111/jgh.13323. PubMedCrossRefGoogle Scholar
  159. 159.
    Zhu Y, Li YG, Wang Y, Wang LP, Wang JB, Wang RL, Wang LF, Meng YK, Wang ZX. Xiao XH (2016) Analysis of clinical characteristics in 595 patients with herb-induced liver injury. Zhongguo Zhong Xi Yi Jie He Za Zhi, CJITWM 36: 43-47.Google Scholar
  160. 160.
    Papafragkakis C, Ona MA, Reddy A, Anand S (2016) Acute hepatitis after ingestion of a preparation of Chinese Skullcap and Black Catechu for joint pain. Case Rep Hepatol 2016:4356749. https://doi.org/10.1155/2016/4356749 Google Scholar
  161. 161.
    Zhang P, Ye Y, Yang X, Jiao Y (2016) Systematic review on Chinese herbal medicine induced liver injury. Evid-Based Complement Alternat Med 2016, 3560812. DOI: https://doi.org/10.1155/2016/3560812
  162. 162.
    Ocak T, Duran A, Katırcı Y, Erkuran MK, Kurt BB (2016) Hepatorenal syndrome associated with the use of Reishi Fungus. J Emerg Medicine Case Rep. http://www.akatos.com/sayilar/231/buyuk/1-1477.pdf
  163. 163.
    Melchart D, Hager S, Dai J, Weidenhammer W (2016) Quality control and complication screening programme of Chinese medicinal drugs at the first German hospital of Traditional Chinese Medicine—a retrospective analysis. Forsch Komplementmed 23:21–28. https://doi.org/10.1159/000444983 PubMedGoogle Scholar
  164. 164.
    Dyson JK, Hutchinson J, Harrison L, Rotimi O, Tiniakos D, Foster GR, Aldersley MA, McPherson S (2016) Liver toxicity associated with sofosbuvir, an NS5A inhibitor and ribavirin use. J Hepatol 64:234–238PubMedCrossRefGoogle Scholar
  165. 165.
    Taneja S, Kumar P, Rathi S, Duseja A, Singh V, Dhiman RK, Chawla Y (2017) Acute liver failiure due to Etodolac, a selective cycloxygenase-2 (COX-2) inhibitor non-steroidal anti-inflammatory drug established by RUCAM-based causality assessment. Ann Hepatol 16(5):818–821PubMedCrossRefGoogle Scholar
  166. 166.
    Ferrajolo C, Verhamme KMC, Trifirò G, ‘t Jong GW, Picelli G, Giaquinto C, Mazzaglia G, Stricker BH, Rossi F, Capuano A, Sturkenboom MC (2017) Antibiotic-induced liver injury in pediatric outpatients: a case-control study in primary care databases. Drug Saf 40(4):305–315PubMedCrossRefGoogle Scholar
  167. 167.
    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 (2011) Causality assessment methods in drug induced liver injury: strengths and weaknesses. J Hepatol 55:683–669PubMedCrossRefGoogle Scholar
  168. 168.
    Takikawa H (2010) Recent status of drug-induced liver injury and its problems in Japan. Jap Med Ass J 53:243–247Google Scholar
  169. 169.
    Teschke R, Eickhoff A, Schulze J (2013) Drug and herb induced liver injury in clinical and translational hepatology: causality assessment methods, quo vadis? J Clin Translat Hepatol 1:59–74Google Scholar
  170. 170.
    Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J, for the DILIN Study Group (2009) Drug-induced liver injury Network (DILIN) prospective study. Rationale, design and conduct. Drug Saf 32:55–68PubMedPubMedCentralCrossRefGoogle Scholar
  171. 171.
    Tajiri K, Shimizu Y (2008) Practical guideline for diagnosis and early management of drug-induced liver injury. World J Gastroenterol 14:6774–6785PubMedPubMedCentralCrossRefGoogle Scholar
  172. 172.
    Teschke R, Wolff A (2011) Regulatory causality evaluation methods applied in kava hepatotoxicity: are they appropriate? Regul Toxicol Pharmacol 59:1–7PubMedCrossRefGoogle Scholar
  173. 173.
    BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn. Federal Institute for Drugs and Medicinal Products in Germany) (2002) Rejection of Drug Risks, Step II. As related to: Kava-Kava (Piper methysticum)-containing, and kavain-containing drugs, including homeopathic preparations with a final concentration up to, and including D4. 14 June 2002. http://www.spc.int/cis/documents/02_0714_BfArM_Kava_Removal.pdf. Last accessed 15 Dec 2016
  174. 174.
    Liss G, Lewis JH (2009) Drug-induced liver injury: what was new in 2008? Expert Opin Drug Metab Toxicol 5:843–860. https://doi.org/10.1517/17425250903018904 PubMedCrossRefGoogle Scholar
  175. 175.
    Teschke R, Schulze J (2012) Suspected herbal hepatotoxicity: requirements for appropriate causality assessment by the US Pharmacopeia. Drug Saf 35:1091–1097PubMedCrossRefGoogle Scholar
  176. 176.
    Teschke R, Schwarzenboeck A, Schmidt-Taenzer W, Wolff A, Hennermann KH (2011) Herb induced liver injury presumably caused by black cohosh: a survey of initially purported cases and herbal quality specifications. Ann Hepatol 11:249–259Google Scholar
  177. 177.
    Teschke R, Schmidt-Taenzer W, Wolff A (2012) USP suspected herbal hepatotoxicity: quality of causality assessment is more important than quantity of counted cases, not vice versa. Pharmacoepidemiol Drug Saf 21:336–338CrossRefGoogle Scholar
  178. 178.
    Mahady GB, Low Dog T, Barrett ML, Chavez ML, Gardiner P, Ko R, Marles RJ, Pellicore LS, Giancaspro GI, Sarma DN (2008) United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause 15:628–638PubMedCrossRefGoogle Scholar
  179. 179.
    Sarma DN, Barrett ML, Chavez ML, Gardiner P, Ko R, Mahady GB, Marles RJ, Pellicore LS, Giancaspro GI, Low Dog T (2008) Safety of green tea extract: a systematic review by the US Pharmacopeia. Drug Saf 31:469–484PubMedCrossRefGoogle Scholar
  180. 180.
    WHO (World Health Organization) (2007) Assessments of the risk of hepatotoxicity with kava products. WHO Document Production Services, Geneva, SwitzerlandGoogle Scholar
  181. 181.
    Teschke R, Eickhoff A, Wolff A, Frenzel C, Schulze J (2013) Herbal hepatotoxicity and WHO global introspection method. Ann Hepatol 12:11–21PubMedGoogle Scholar
  182. 182.
    Teschke R, Andrade R (2015) Editorial. Drug-induced liver injury: expanding our knowledge by enlarging population analysis with prospective and scoring causality assessment. Gastroenterology 148:1271–1273. https://doi.org/10.1053/j.gastro.2015.04.027. PubMedCrossRefGoogle Scholar

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© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Division of Gastroenterology and Hepatology, Department of Internal Medicine IIKlinikum HanauHanauGermany
  2. 2.Academic Teaching Hospital of the Medical FacultyGoethe University Frankfurt/MainFrankfurt am MainGermany
  3. 3.Pharmacovigilance ConsultancyParisFrance

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