medigraphic.com
Órgano Oficial de la Asociación Mexicana de Hepatología

2013, Number 1

<< Back Next >>

Ann Hepatol 2013; 12 (1)

Herbal hepatotoxicity and WHO global introspection method

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

Language: English
References: 65
Page: 11-21
PDF size: 124.04 Kb.


ABSTRACT

Herbal hepatotoxicity is a rare but highly disputed disease because numerous confounding variables may complicate accurate causality assessment. Case evaluation is even more difficult when the WHO global introspection method (WHO method) is applied as diagnostic algorithm. This method lacks liver specificity, hepatotoxicity validation, and quantitative items, basic qualifications required for a sound evaluation of hepatotoxicity cases. Consequently, there are no data available for reliability, sensitivity, specificity, positive and negative predictive value. Its scope is also limited by the fact that it cannot discriminate between a positive and a negative causality attribution, thereby stimulating case overdiagnosing and overreporting. The WHO method ignores uncertainties regarding daily dose, temporal association, start, duration, and end of herbal use, time to onset of the adverse reaction, and course of liver values after herb discontinuation. Insufficiently considered or ignored are comedications, preexisting liver diseases, alternative explanations upon clinical assessment, and exclusion of infections by hepatitis A-C, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus (HSV), and varicella zoster virus (VZV). We clearly prefer as alternative the scale of CIOMS (Council for International Organizations of Medical Sciences) which is structured, quantitative, liver specific, and validated for hepatotoxicity. In conclusion, causality of herbal hepatotoxicity is best assessed by the liver specific CIOMS scale validated for hepatotoxicity rather than the obsolete WHO method that is liver unspecific and not validated for hepatotoxicity. CIOMS based assessments will ensure the correct diagnosis and exclude alternative diagnosis that may require other specific therapies.


REFERENCES

  1. Colalto C. Unpredictable adverse reactions to herbal products. J Drug Metab Toxicol 2012; 3: 2. Available at: http://www.omicsonline.org/2157-7609/2157-7609-3- e105.pdf [Accessed October 15, 2012].

  2. Navarro VJ. Herbal and dietary supplement hepatotoxicity. Semin Liver Dis 2009; 29: 373-82.

  3. Teschke R, Lebot V. Proposal for a Kava Quality Standardization Code. Food Chem Toxicol 2011; 49: 2503-16.

  4. Teschke R, Qiu SX, Xuan TD, Lebot V. Kava and kava hepatotoxicity: requirements for novel experimental, ethnobotanical, and clinical studies based on a review of the evidence. Phytother Res 2011; 25: 1262-74.

  5. Elinav E, Pinkser G, Safadi R, Pappo O, Bromberg M, Anis E, Keinan-Boker L, et al. Association between consumption of Herbalife® nutritional supplements and acute hepatotoxicity. J Hepatol 2007; 47: 514-20.

  6. Schoepfer AM, Engel A, Fattinger K, Marbet UA, Criblez D, Reichen J, Zimmermann A, et al. Herbal does not mean innocuous: ten cases of severe hepatotoxicity associated with dietary supplements from Herbalife products. J Hepatol 2007; 47: 521-6.

  7. Jóhannsson M, Ormarsdóttir S, Olafsson S. Hepatotoxicity associated with the use of Herbalife. Laeknabladid 2010; 96: 167-72.

  8. Manso G, López-Rivas L, Salgueiro ME, Duque JM, Jimeno FJ, Andrade RJ, Lucena MI. Continuous reporting of new cases in Spain supports the relationship between Herbalife products and liver injury. Pharmacoepidemiol Drug Saf 2011; 20: 1080-7.

  9. Teschke R, Glass X, Schulze J. Herbal hepatotoxicity by Greater Celandine (Chelidonium majus): Causality assessment of 22 spontaneous reports. Regul Toxicol Pharmacol 2011; 61: 282-91.

  10. Teschke R, Frenzel C, Glass X, Schulze J, Eickhoff A. Greater Celandine hepatotoxicity: A clinical review. Ann Hepatol 2012; 11: 838-48.

  11. Teschke R, Wolff A, Frenzel C, Schulze J, Eickhoff A. Herbal hepatotoxicity: A tabular compilation of reported cases. Liver Int 2012. In press. DOI: 10.1111/ j.1478-3231.2012.02864x.

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

  13. BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn. Federal Institute for Drugs and Medicinal Products in Germany). 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. June 14, 2002. Available at: http://www.spc.int/cis/ documents/02_0714_BfArM_Kava_Removal.pdf [Accessed October 15, 2012].

  14. Benninger J, Schneider HT, Schuppan D, Kirchner T, Hahn EG. Acute hepatitis induced by Greater Celandine (Chelidonium majus). Gastroenterology 1999; 117: 1234-7.

  15. Dara L, Hewett J, Lim JK. Hydroxycut hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements. World J Gastroenterol 2008; 14: 6999-7004.

  16. Inoue H, Yamazaki S, Shimizu M, Uozki H, Goto T, Ohnishi S, Koike K. Liver injury induced by the Japanese herbal drug kamishoyosan. Gastroenterol Hepatol 2011: 7: 692-5.

  17. Mahady GB, Low Dog T, Barrett ML, Chavez ML, Gardiner P, Ko R, Marles RJ, et al. United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause 2008; 15: 628-38.

  18. Sarma DN, Barrett ML, Chavez ML, Gardiner P, Ko R, Mahady GB, Marles RJ, et al. Safety of green tea extract: a systematic review by the US Pharmacopeia. Drug Saf 2008; 31: 469-84.

  19. WHO (World Health Organization). Assessments of the risk of hepatotoxicity with kava products. Geneva, Switzerland: WHO Document Production Services; 2007.

  20. Teschke R, Frenzel C, Schulze J, Eickhoff A. Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: Was causality adequately ascertained? Regul Toxicol Pharmacol 2012; 63: 1-9.

  21. Teschke R, Frenzel C, Wolff A, Herzog J, Glass X, Schulze J, Eickhoff A. Initially purported hepatotoxicity by Pelargonium sidoides: the dilemma of pharmacovigilance and proposals for improvements. Ann Hepatol 2012; 11: 500-12.

  22. EMA: Assessment of case reports connected to herbal medicinal products containing cimicifugae racemosae rhizoma (black cohosh, root). Issued May 8, 2007. Available at: h t t p : / / w w w . e m a . e u r o p a . e u / d o c s / e n _ G B / document_library/Herbal_-_HMPC_assessment_report/ 2010/02/WC500074167.pdf [Accessed October 15, 2012].

  23. Teschke R, Schwarzenboeck A, Hennermann KH. Kava hepatotoxicity: a clinical survey and critical analysis of 26 suspected cases. Eur J Gastroenterol Hepatol 2008; 20: 1182-93.

  24. García-Cortés M, Borraz Y, Lucena MI, Peláez G, Salmerón J, Diago M, Martínez-Sierra MC, et al. Liver injury induced by “natural remedies”: an analysis of cases submitted to the Spanish Liver Toxicity Registry. Rev Esp Enferm Dig 2008; 100: 688-95 (Article in Spanish).

  25. Teschke R, Schmidt-Taenzer W, Wolff A. Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: Is the liver unspecific Naranjo scale precise enough to ascertain causality? Pharmacoepidemiol Drug Saf 2011; 20: 567-82.

  26. Teschke R, Glass X, Schulze J, Eickhoff A. Suspected Greater Celandine hepatotoxicity: Liver specific causality evaluation of published case reports from Europe. Eur J Gastroenterol Hepatol 2012; 24: 270-80.

  27. Liss G, Lewis JH. Drug-induced liver injury: what was new in 2008? Expert Opin Drug Metab Toxicol 2009; 5: 843-60.

  28. Teschke R. Letter to the Editor: United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause 2009; 16: 214.

  29. Mahady G, Low Dog T, Sarma DN. Letter to the Editor (Reply). Menopause 2009; 16: 214-5.

  30. Teschke R, Bahre R, Genthner A, Fuchs J, Schmidt-Taenzer W, Wolff A. Suspected black cohosh hepatotoxicity- Challenges and pitfalls of causality assessment. Maturitas 2009; 63: 302-14.

  31. Mahady GB, Low Dog T, Sarma DN, Giancaspro GI. Letter to the Editor. Suspected black cohosh hepatotoxicity- Causality assessment versus safety signal. Maturitas 2009; 64: 139-40.

  32. Teschke R, Bahre R, Genthner A, Fuchs J, Schmidt-Taenzer W, Wolf A. Suspected black cohosh hepatotoxicity- Causality assessment versus safety signal. Quality versus quantity. Maturitas 2009; 64: 141-2.

  33. Teschke R. Black cohosh and suspected hepatotoxicity-inconsistencies, confounding variables, and prospective use of a diagnostic causality algorithm: A critical review. Menopause 2010; 17: 426-40.

  34. Mahady G, Low Dog T, Sarma ND, Giancaspro GI, Griffiths J. Letter to the Editor. Menopause 2010; 17: 1088-9.

  35. Teschke R. Letter to the editor: In response. Menopause 2010; 17: 1089.

  36. Teschke R, Wolff A. Regulatory causality evaluation methods applied in kava hepatotoxicity: Are they appropriate? Regul Toxicol Pharmacol 2011; 59: 1-7.

  37. Teschke R, Schwarzenboeck A, Schmidt-Taenzer W, Wolff A, Hennermann KH. Herb induced liver injury presumably caused by black cohosh: A survey of initially purported cases and herbal quality specifications. Ann Hepatol 2011; 11: 249-59.

  38. Mahady G, Dog T, Sarma ND, Griffiths J, Giancaspro G. Letter to the Editor. Pharmacoepidemiol Drug Saf 2012; 21: 339-40.

  39. Teschke R, Schmidt-Taenzer W, Wolff A. USP suspected herbal hepatotoxicity: Quality of causality assessment is more important than quantity of counted cases, not vice versa. Pharmacoepidemiol Drug Saf 2012; 21: 336-38.

  40. Stammschulte T, Gundert-Remy U. Letter to the Editor. Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: Was causality adequately ascertained? Regul Toxicol Pharmacol 2012. In press. Available at: http://dx.doi.org.10.101016/ j.yrtph.2012.06.011 [Accessed October 15, 2012].

  41. Teschke R, Frenzel C, Schulze J, Eickhoff A. Suspected herbal hepatotoxicity: the pharmacovigilance dilemma with disputed and obsolete evaluation methods. Regul Toxicol Pharmacol 2012. In press. Available at: http://dx.doi.org/10.1016/ j.yrtph.2012.06.010 [Accessed October 15, 2012].

  42. Teschke R, Schulze J. Suspected herbal hepatotoxicity: Requirements for appropriate causality assessment by the US Pharmacopeia. Drug Saf 2012. In press. DOI: 10.2165.11631960-000000000-00000.

  43. Teschke R, Frenzel C, Glass X, Schulze J, Eickhoff A. Herbal hepatotoxicity: A critical review. Br J Clin Pharmacol. In press. DOI: 10.1111/j.1365-2125.2012.04395.x

  44. Karch FE, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther 1977; 21: 247-54.

  45. García-Cortés M, Stephens C, Lucena MI, Fernández-Castańer 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.

  46. 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.

  47. Zimmerman HJ. Hepatotoxicity. Philadelphia: Lippincott Williams & Wilkins; 1999.

  48. Lee WM. Drug-induced hepatotoxicity. N Engl J Med 2003; 349: 474-85.

  49. Lee WM, Senior JR. Recognizing drug-induced liver injury: Current problems, possible solutions. Toxicol Pathol 2005; 33: 155-64.

  50. Watkins PB, Seeff LB. Drug-induced liver injury: Summary of a single topic clinical research conference. Hepatology 2006; 43: 618-31.

  51. Teschke R, Schwarzenboeck A, Hennermann KH. Causality assessment in hepatotoxicity by drugs and dietary supplements. Br J Clin Pharmacol 2008; 66: 758-66.

  52. Andrade RJ, Camargo R, Lucena MI, González-Grande R. Causality assessment in drug-induced hepatotoxicity. Expert Opin Drug Saf 2004; 3: 329-44.

  53. WHO, World Health Organization. The use of the WHOUMC system for standardised case causality assessment. WHO Collaboratoring Centre for International Drug Monitoring (Uppsala Monitoring Centre, UMC), Database 2000. Available at: http://who-umc.org/Graphics/24734.pdf [Accessed October 15, 2012].

  54. 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.

  55. 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.

  56. Teschke R. Kava hepatotoxicity-a clinical review. Ann Hepatol 2010; 9: 251-65.

  57. Kramer MS. Assessing causality of adverse drug reactions: Global introspection and its limitations. Drug Inf J 1986; 20: 433-7.

  58. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Pelargoniumhaltige Arzneimittel: Risiko von Leberschädigungen, 28.6. 2012. Available at: http:// www.bfarm.de [Accessed October 15, 2012].

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

  60. Bernal W, Auzinger G, Dhawan A, Wendon J. Acute liver failure. Lancet 2010; 376: 190-201.

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

  62. 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.

  63. Macedo AF, Marques FB, Ribeiro CF, Teixeira F. Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel, according to different levels of imputability. J Clin Pharm Ther 2003; 28: 137-43.

  64. Karch FE, Smith CL, Kerzner B, Mazullo JM, Weintraub M, Lasagna L. Adverse drug reactions a matter of opinion. Clin Pharmacol Ther 1976; 19: 489-92.

  65. Blanc S, Levenberger P, Berger JP, Brooke EM, Schelling JL. Judgements of trained observers on adverse drug reactions. Clin Pharmacol Ther 1979; 25: 493-8.




2020     |     www.medigraphic.com