Hepatotoxicity by drugs and dietary supplements: Safety perspectives on clinical and regulatory issues

Annals of Hepatology

Volumn 8, Issue 3, 2009, Pages 184-195

  Teschke, Rolf ^a,b  

^a Klinikum Hanau   (Germany)

^b UNIVERSITY HOSPITAL FRANKFURT   (Germany)

Author keywords

Dietary supplements; Drugs; Hepatotoxicity; Regulatory agencies; Safety perspectives

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BIOLOGICAL MARKER; GAMMA GLUTAMYLTRANSFERASE;

ALGORITHM; ARTICLE; CAUSAL ATTRIBUTION; CLINICAL ASSESSMENT; DIAGNOSTIC ACCURACY; DIAGNOSTIC ERROR; DIAGNOSTIC VALUE; DIET SUPPLEMENTATION; DRUG CONTROL; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; GOVERNMENT REGULATION; HIGH RISK PATIENT; HUMAN; LIVER TOXICITY; PREDICTIVE VALUE; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; RISK FACTOR; SENSITIVITY AND SPECIFICITY; DRUG EFFECT; DRUG TOXICITY; LIVER; OUTCOME ASSESSMENT; REVIEW; TOXICITY TESTING;

ALGORITHMS; DIETARY SUPPLEMENTS; DRUG TOXICITY; HUMANS; LIVER; OUTCOME ASSESSMENT (HEALTH CARE); TOXICITY TESTS;

EID: 77952499811     PISSN: 16652681     EISSN: None     Source Type: Journal    
DOI: 10.1016/s1665-2681(19)31764-8     Document Type: Article

References (58)

1. Zimmerman HJ. Hepatotoxicity. Lippincott Williams & Wilkins, Philadelphia; 1999.
2. Pugh AJ, Barve AJ, Falkner K, Patel M, McClain CJ. Drug-induced hepatotoxicity or drug-induced liver injury. Clin Liver Dis 2009; 13(2): 277-94.
3. Lee WM. Drug-induced hepatotoxicity. N Engl J Med 2003; 349: 474-485.
4. Papay JI, Clines D, Rafi R, Yuen N, Britt SD, Walsh JS, Hunt CM. Drug-induced liver injury following positive drug recha-llenge. Regul Toxicol Pharmacol 2009; 54(1): 84-90.
5. Teschke R, Schwarzenboeck A, Hennermann KH. Causality assessment in hepatotoxicity by drugs and dietary supplements. Br J Clin Pharmacol 2008; 66: 758-766.
6. Willett KL, Roth RA, Walker L. Workshop overview: hepatotoxicity assessment for botanical dietary supplements. Toxicol Sci 2004; 79: 4-9.
7. Teschke R, Genthner A, Wolff A. Kava hepatotoxicity: Comparison of aqueous, ethanolic, acetonic kava extracts and kava-herbs mixtures. Ethnopharmacol 2009; 123: 378-384.
8. Teschke R, Wolff A. Kava hepatotoxicity: Regulatory data selection and causality assessment. Dig Liver Dis 2009. doi:10.1016/i.dld.2009.04.003.
9. Maddrey WC. Drug-induced hepatotoxicity. J Clin Gastroenterol 2005; 39: S83-S89.
10. Larrey D, Pageaux GP. Drug-induced acute liver failure. Eur J Gastroenterol Hepatol 2005; 17: 141-143.
11. Peters TS. Do preclinical testing strategies help predict human hepatotoxic potentials? Toxicol Pathol 2005; 33: 146-154.
12. Woodward KN. The potential impact of the use of homeopathic and herbal remedies on monitoring the safety of prescription products. Human Exp Toxicol 2005; 24: 219-233.
13. De Smet PAGM. Herbal medicine in Europe - relaxing regulatory standards. N Engl J Med 2005; 352: 1176-1178.
14. Comar KM, Kirby DF. Herbal remedies in gastroenterology. J Clin Gastroenterol 2005; 39: 457-468.
15. Corns CM. Herbal remedies and clinical biochemistry. Ann Clin Biochem 2003; 40: 489-507.
16. De Smet PAGM. Herbal remedies. N Engl J Med 2002; 347: 2046-2056.
17. Techke R, Bahre R, Genthner A, Fuchs J, Schmidt-Taenzer W, Wolff A. Suspected black cohosh hepatotoxicity - Challenges and pitfalls of causality assessment. Maturitas 2009. doi:10.1016/i.maturitas.2009.05.006.
18. Lewis JD, Strom BL. Balancing safety of dietary supplements with the free market. Ann Intern Med 2002: 136: 616-618.
19. Watkins PB. Idiosyncratic liver injury: challenges and approaches. Toxicol Pathol 2005; 33: 1-5.
20. Teschke R, Schwarzenboeck A, Hennermann KH. Kava hepato-toxicity: A clinical survey and critical analysis in 26 suspected cases. Eur J Gastroenterol Hepatol 2008; 20: 1182-1193.
21. Björnsson E, Olsson R. Suspected drug-induced liver fatalities reported to the WHO database. Dig Liver Dis 2006; 38: 33-38.
22. Andrade RJ, Lucena MI, Fernandez MC, Pelaez G, Pachkoria K, Garcia-Ruiz E, et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 2005; 129: 512-521.
23. Björnsson E, Olsson R. Outcome and prognostic markers in severe drug-induced liver disease. Hepatology 2005; 42: 481-489.
24. de Abajo FJ, Montero D, Madurga M, Rodriguez LAG. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br J Clin Pharmacol 2004; 58: 7180.
25. Durazo FA, Lassman C, Han SHB, Saa S, Lee NP, Kawano M, et al. Fulminant liver failure due to usnic acid for weight loss. Am J Gastroenterol 2004; 99: 950-952.
26. Teschke R, Gaus W, Loew D. Kava extracts: safety and risks including rare hepatotoxicity. Phytomedicine 2003; 10: 440-446.
27. Estes JD, Stolpman D, Olyaei A, Corless CL, Ham JM, Schwartz JM, et al. High prevalence of potentially hepatotoxic herbal supplement use in patients with fulminant hepatic failure. Arch Surg 2003; 138: 852-858.
28. Adachi M, Saito H, Kobayashi H, Horie Y, Kato S, Yoshioka M, et al. Hepatic injury in 12 patients taking the herbal weight loss aids Chaso or Onshido. Ann Intern Med 2003; 139: 48892.
29. Graham DJ, Drinkard CR, Shatin D. Incidence of idiopathic acute liver failure and hospitalized liver injury in patients treated with troglitazone. Am J Gastroenterol 2003; 98: 1759.
30. Bleibel W, Kim S, D'Silva K, Lemmer ER. Drug-induced liver injury: review article. Dig Dis Sci 2007; 52: 2463-2471.
31. Chang CY, Schiano TD. Review article: drug hepatotoxicity. Aliment Pharmacol Ther 2007; 25: 1135-1151.
32. Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology 2006; 43: 618-631.
33. BfArM (Bundesinstitut fur Arzneimittel und Medizinprodukte, Bonn. Federal Institute for Drugs and Medicinal Products in Germany). Available at: http://www.bfarm.de/de/arzneimit-tel/am_sicher/stufenpl/Besch-kava-Final.pdf [Accessed: June 14, 2002].
34. MCA (Medicine Control Agency). Line listing February 14, 2002.
35. EMEA (European Medicine Agency). Line listing July 10, 2002.
36. Schmidt M, Morgan M, Bone K, McMillan J. Kava: a risk-benefit assessment. In: Mills M, Bone K (eds.). The essential guide to herbal safety. St. Louis, MO: Elsevier Churchill Livingstone; 2005, p. 155-221.
37. EMEA. Assessment of case reports connected to herbal medicinal products containing cimicifugae racemosae rhizoma (black cohosh, root). Available at: http://www.emea.europa.eu/pdfs/human/hmpc/26925806en.pdf. [Accessed: July 18, 2006].
38. Teschke R. Questions regarding causality in presumed black cohosh hepatotoxicity. Del Med J 2008; 80: 233-234.
39. Teschke R. Letter to the Editor: United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause 2009; 16: 214.
40. Teschke R. Letter to the Editor: Liver failure associated with the use of black cohosh for menopausal symptoms. Med J Aust 2009; 190: 99-100.
41. 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: 1331-1336.
42. 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: 123-130.
43. Aithal PG, Day CP. The natural history of histologically proved drug induced liver disease. Gut 1999; 44: 731-735.
44. Teschke R, Schwarzenboeck A. Suspected hepatotoxicity by cimicifugae racemosae rhizoma (black cohosh, root): critical analysis and structured causality assessment. Phytomedicine 2008; 16: 72-84.
45. Aithal GP, Rawlins MD, Day CP. Accuracy of hepatic adverse drug reaction reporting in one English health region. BMJ 1999; 319: 1541.
46. Danan G, Bénichou C, Begaud B, Biour M, Couzigou P, Evreux JC, et al. Critères d'imputation d'une hépatite aiguë à un médicament. Résultats de réunions de consensus. Gastroenterol Clin Biol 1987; 11: 581-585.
47. Danan G. Consensus meetings on: causality assessment of drug-induced liver injury. J Hepatol 1988; 7: 132-136.
48. Bénichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol 1990; 11: 272-276.
49. 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: 1323-1330.
50. Maria VAJ, Victorino RMM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology 1997; 26: 664-669.
51. Aithal GP, Rawlins MD, Day CP. Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions. J Hepatol 2000; 33: 949-952.
52. Takamori Y, Takikawa H, Kumagi T, Watanabe M, Shibata A, Hisamochi A, et al. Assessment of the diagnostic scale for drug induced liver injury (DILI) by the international consensus meeting (ICM) and a proposal of it modifications. Hepatology 2003; 38(Suppl. 1): 703A.
53. Andrade RJ, Camargo R, Lucena MI, Gonzalez-Grande R. Causality assessment in drug-induced hepatotoxicity. Expert Opin Drug Saf 2004; 3: 329-344.
54. Lewis JH. Drug-induced liver disease. Curr Opin Gastroente-rol 2002; 18: 307-313.
55. Mahady GB, Low Dog T, Barrett ML, Chavez ML, Gardiner P, Ko R, et al. United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause 2008; 15: 628-635.
56. Teschke R, Bahre R, Fuchs J, Wolff A. Black cohosh hepato- toxicity: quantitative causality evaluation in suspected nine cases. Menopause 2009. DOI:10.1097/GME.0b013e31819d3904.
57. Teschke R, Schwarzenboeck A, Akinci A. Kava hepatotoxicity: a European view. N Zeal M J 2008; 121:1283; ISSN 1175 8716. Available at: http://www.nzma.org.nz/journal/121-1283
58. Schmidt M. Quality criteria for kava. HerbalGram 2007; 73: 45-49.