Teschke R, Frenzel C, Glass X, Schulze J, Eickhoff A

Language: English
References: 36
Page: 838-848
PDF size: 124.25 Kb.

ABSTRACT

Herbal hepatotoxicity is a rare and poorly described disease because reported cases are mostly scattered and lack an appropriate causality assessment. We now describe in detail the clinical picture of herbal hepatotoxicity by extracts of Greater Celandine (GC), syn. Chelidonium majus L. from the Papaveraceae family, which contain more than 20 ingredients including various biologically active isoquinoline alkaloids. For this purpose, we analyzed and reviewed published cases of 16 patients from various European countries. In all patients, herbal hepatotoxicity was of probable and highly probable causality for GC, using the original and updated scale of CIOMS (Council for International Organizations of Medical Sciences). GC associated hepatotoxicity usually has an acute clinical course exhibiting a hepatocellular pattern of injury and is correlated to an idiosyncratic reaction with its metabolic subtype. Jaundice combined with high values of serum aminotransferases was present in virtually all cases with favourable outcome despite severe clinical course. In conclusion, GC hepatotoxicity is a typical herbal hepatotoxicity with a sound causality track for GC, but there is uncertainty regarding the respective causative compound(s). The present detailed review of GC hepatotoxicity may serve as an example for clinical causality assessments of future cases of liver injury due to other herbs.

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 July 31, 2012].

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

3. Vahlensieck U, Hahn R, Winterhoff H, Gumbinger HG, Nahrstedt A, Kemper FH. The effect of Chelidonium majus herb extract on choleresis in the isolated perfused rat liver. Planta Med 1995; 61: 267-70.

4. Blumenthal M. The complete German commission E monographs: Therapeutic guide of herbal medicines. American Botanical Council, Austin, Texas (USA), 1998.

5. Bundesinstitut für Arzneimittel und Medizinprodukte. Bekanntmachung. Abwehr von Gefahren durch Arzneimittel, Stufe II, Anhörung: Schöllkraut-haltige Arzneimittel zur innerlichen Anwendung. May 6, 2005. Available at: http:// www.bfarm.de/cae/servlet/contentblob/1014620/publicationFile/ 66198/schoellkraut-anhoerung_050505.pdf [Accessed July 31, 2012].

6. Strahl S, Ehret V, Dahm HH, Maier KP. Necrotizing hepatitis after taking herbal medication (extracts of kava or of common or lesser celandine). Dtsch Med Wschr 1998; 123: 1410-14 [Article in German].

7. Greving I, Meister V, Monnerjahn C, Müller KM, May B. Chelidonium majus: a rare reason for severe hepatotoxic reaction. Pharmacoepidemiol Drug Saf 1998; 7: S66-S69.

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

9. Crijns AP, de Smet PA, van den Heuvel M, Schot BW, Haagsma EB. Acute hepatitis after use of herbal preparation with greater celandine (Chelidonium majus). Ned Tijdschr Geneeskd 2002; 146: 124-128 [Article in Dutch].

10. Stickel F, Pöschl G, Seitz HK, Waldherr R, Hahn EG, Schuppan D. Acute hepatitis induced by Greater Celandine (Chelidonium majus). Scand J Gastroenterol 2003; 38: 565-8.

11. Rifai K, Flemming P, Manns MP, Trautwein C. Severe drug hepatitis caused by Chelidonium majus. Internist 2006; 47: 749-51 [Article in German].

12. Hardeman E, van Overbeke L, Ilegems S, Ferrante M. Acute hepatitis induced by greater celandine (Chelidonium majus). Acta Gastroenterol Belg 2003; 71: 281-2.

13. Conti E, De Checchi G, Mencarelli R, Pinato S, Rovere P. Lycopodium similiaplex-induced acute hepatitis: a case report. Eur J Gastroenterol Hepatol 2008; 20: 469-71.

14. Moro PA, Cassetti F, Giugliano G, Falce MT, Mazzanti G, Menniti-Ippolito F, Raschetti R, Santuccio C. Hepatitis from Greater celandine (Chelidonium majus L.): Review of literature and report of a new case. J Ethnopharmacol 2009; 124: 328-32.

15. Tarantino G, Di Minno MND, Pezullo MG, Pezzullo LS, Milone F, Milone M, Capone D. Drug-induced liver injury due to “natural products” used for weight loss: A case report. World J Gastroenterol 2009; 15: 2414-17.

16. 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.

17. 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.

18. 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.

19. Björnsson E, Olsson R. Suspected drug-induced liver fatalities reported to the WHO database. Dig Liver Dis 2006; 38: 33-8.

20. 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.

21. Schulze J, Raasch W, Siegers CP. Toxicity of kava pyrones, drug safety and precautions- a case study. Phytomedicine 2003; 10(Suppl. IV): 68-73.

22. Teschke R, Wolff A. Kava hepatotoxicity: Regulatory data selection and causality assessment. Dig Liv Dis 2009; 41: 891-901.

23. 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.

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

25. Teschke R. Hepatotoxicity by drugs and dietary supplements: safety perspectives on clinical and regulatory issues. Ann Hepatol 2009; 8: 184-95.

26. 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.

27. Zimmerman HJ. Hepatotoxicity. Lippincott Williams & Wilkins, Philadelphia (1999).

28. 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: 1331-36.

29. 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.

30. Teschke R, Bahre R. Severe hepatotoxicity by Indian Ayurvedic herbal products: A structured causality assessment. Ann Hepatol 2009; 8: 258-66.

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

32. Mazzanti G, Di Sotto A, Franchitto A, Mammola CL, Mariani P, Mastrangelo S, Menniti-Ippolito F, Vitalone A. Chelidonium majus is not hepatotoxic in Wistar rats, in a 4 weeks feeding experiment. J Ethnopharmacol 2009; 126: 518-24.

33. Björnsson E, Olsson R. Outcome and prognostic markers in severe drug-induced liver disease. Hepatology 2005; 42: 481-9.

34. Colombo ML, Bosisio E. Pharmacological activities of Chelidonium majus L. (Papaveraceae). Pharmacol Res 1996; 33: 127-34.

35. Mammola C, Vitalone A, Di Sotto A, Mariani P, Izzo P, Mazzanti G. In vitro and in vivo studies on the hepatic effect of acute administration of Chelidonium majus alone or in association with acetaminophen. Italian J Anat Embryol 2010; 115 [1/2 (Supplement)]: 97.

36. Rudolf H, Ullrich A, Ludwig K, Runge D. Hepatotoxic assessment of Chelidonium majus L. and its alkaloids in primary cultures of different species. Available at: http:// www.hepatozyten.de/pdf/Schoellkraut.pdf [Accessed July 31, 2012].