INTRODUCTION
	1. Total Listed Cases
	2. Duplicate Entries
	3. Side Effects With No Relationship to the Ingestion of Kava
	4. Causal relationship with concomitant medication probable
	5. Doubtful Causality
	6. Causal relationship cannot be evaluated due to information status
	7. Causal relationship probable at monograph-conforming dosage
	8. Probable cause relationship related to overdosage of kava extract
	9. Literature

Analysis of Kava Side Effects Reports Concerning the Liver

Translation to English by Lindenmaier M and Brinckmann J
31. December 2001

Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)

9. Literature [1] Anonym. Konsequenzen für Kava-Präparate in der Schweiz. Pharm Ztg 2000; 145(42):3494. [2] Arzneimittelkommission der Deutschen Apotheker. Kava-Kava und Kavain-haltige Arzneimittel. Pharm Ztg 2001; 146(46):4017. [3] Arzneimittelkommission der Deutschen Apotheker. Kava-Präparate und Kavain-haltige Arzneimittel. Dtsch Apoth Ztg 2001; 141(46):5412. [4] Barrio J, Castiella A, Cosme A, Lopez P, Fernandez J, Arenas JI. [Hepatotoxicity caused by cloxacillin]. Rev Esp Enferm Dig 1997; 89(7):559-560. [5] Barrio J, Castiella A, Lobo C, Indart A, Lopez P, Garcia-Bengoechea M et al. [Cholestatic acute hepatitis induced by amoxycillin-clavulanic acid combination. Role of ursodeoxycholic acid in drug-induced cholestasis]. Rev Esp Enferm Dig 1998; 90(7):523-526. [6] Bauer TM, Bircher AJ. Drug-induced hepatocellular liver injury due to benzylpenicillin with evidence of lymphocyte sensitization. J Hepatol 1997; 26(2):429-432. [7] Beeley L, Gourevitch A, Kendall MJ. Jaundice after oral penicillin. Lancet 1976; 2(7998):1297. [8] Benichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol 1990; 11(2):272-276. [9] Bint AJ. Esters of penicillins--are they hepatotoxic? J Antimicrob Chemother 1980; 6(6):697-699. [10] Bralet MP, Zafrani ES. [Hepatitis caused by the amoxicillin-clavulanic acid combination. An example of drug-induced biliary hepatotoxicity]. Ann Pathol 1996; 16(6):425-429. [11] Brauer R-B, Pfab R, Becker K, Berger H, Stangl M. Fulminantes Leberversagen nach Einnahme des pflazlichen Heilmittels Kava-Kava. Z Gastroenterol 2001; 39:491. [12] Bustamante BM, Perez AF, Rayon MM, Garcia HA, Berenguer LJ. [Cholestatic hepatitis caused by amoxycillin-clavulanic acid. Report of a new case]. Gastroenterol Hepatol 1997; 20(4):187-189. [13] Caballero Plasencia AM, Valenzuela BM, Martin Ruiz JL, Guilarte Lopez-Manas J. [Hepatotoxicity caused by amoxicillin, clavulanic acid or both?]. Gastroenterol Hepatol 1997; 20(1):45-46. [14] Escher M, Desmeules J. Hepatitis associated with Kava, a herbal remedy for anxiety. Br Med J 2001; 322(20.01.01):139. [15] Farrell GC. Drug-induced hepatic injury. J Gastroenterol Hepatol 1997; 12(9-10):S242-S250. [16] Galindo C, Buenestado J, Rene JM, Pinol MC. [Acute pancreatitis associated with hepatotoxicity induced by amoxicillin-clavulanic acid]. Rev Esp Enferm Dig 1995; 87(8):597-600. [17] George DK, Crawford DH. Antibacterial-induced hepatotoxicity. Incidence, prevention and management. Drug Saf 1996; 15(1):79-85. [18] Goland S, Malnick SD, Gratz R, Feldberg E, Geltner D, Sthoeger ZM. Severe cholestatic hepatitis following cloxacillin treatment. Postgrad Med J 1998; 74(867):59-60. [19] Goldstein LI, Ishak KG. Hepatic injury associated with penicillin therapy. Arch Pathol 1974; 98(2):114-117. [20] Hautekeete ML. Hepatotoxicity of antibiotics. Acta Gastroenterol Belg 1995; 58(3-4):290-296. [21] Hewitt J, Hammond L. Adverse hepatic events associated with drug therapy. Med J Aust 1996; 165(6):347, 350. [22] Kraft M, Spahn TW, Menzel J, Senninger N, Dietl K-H, Herbst H et al. Fulminantes Leberversagen nach Einahme des pflanzlichen Antidepressivums Kava-Kava. Dtsch med Wschr 2001; 126(36):970-972. [23] Kurowski V. [Cholestatic jaundice induced by amoxicillin and clavulanic acid]. Dtsch Med Wochenschr 1996; 121(12):390-391. [24] Larrey D, Palazzo L, Benhamou JP. Terfenadine and hepatitis. Ann Intern Med 1985; 103(4):634. [25] Mizoguchi Y, Iwasaki M, Tsutsui H, Kobayashi K, Monna T, Morisawa S. Preparation of a drug-induced allergic hepatic disorder model with penicillin as hapten. Osaka City Med J 1991; 37(2):133-140. [26] Olans RN, Weiner LB. Reversible oxacillin hepatotoxicity. J Pediatr 1976; 89(5):835-838. [27] Onate J, Montejo M, Aguirrebengoa K, Ruiz-Irastorza G, Gonzalez dZ, Aguirre C. Hepatotoxicity associated with penicillin V therapy. Clin Infect Dis 1995; 20(2):474-475. [28] Paine TF, Jr. Updating the side effects of the penicillins. Zhonghua Min Guo Wei Sheng Wu Xue Za Zhi 1978; 11(3):104-109. [29] Perman E. [A severe adverse effect of penicillin on the liver. Drug insurance covered the compensation]. Lakartidningen 1998; 95(34):3536. [30] Russmann S, Escher M, Stoller R, Lauterburg BH. Hepatotoxicity of Kava Kava (Piper methysticum) containing herbal drugs. Recent cases in Switzerland and investigations regarding the mechanism. J Exp Klin Pharmakol Toxicol 2001; 363(4):S40. [31] Russmann S, Lauterburg BH, Helbling A. Kava hepatotoxicity. Ann Int Med 2001; 135(1):68-69. [32] Sahai A, Villeneuve JP. Terfenadine-induced cholestatic hepatitis. Lancet 1996; 348(9026):552-553. [33] Saß M, Schnabel S, Kröger J, Liebe S, Schareck WD. Akutes Leberversagen durch Kava-Kava - eine seltene Indikation zur Lebertransplantation. Z Gastroenterol 2001; 39:491. [34] Silvain C, Fort E, Levillain P, Labat-Labourdette J, Beauchant M. Granulomatous hepatitis due to combination of amoxicillin and clavulanic acid. Dig Dis Sci 1992; 37(1):150-152. [35] Stoller R. Leberschädigungen unter Kava-Extrakten. Schweiz Ärzteztg 2000; 81(24):1335-1336. [36] Strahl S, Ehret V, Dahm HH, Maier KP. Nekrotisierende Hepatitis nach Einnahme pflanzlicher Heilmittel. Dtsch med Wschr 1998; 123:1410-1414. [37] Weber E. Taschenbuch der unerwünschten Arzneimittelwirkungen. 2 ed. Stuttgart, New York: Gustav Fischer Verlag, 1988. [38] Westphal JF, Vetter D, Brogard JM. Hepatic side-effects of antibiotics. J Antimicrob Chemother 1994; 33(3):387-401. [39] Yusoff IF, Nairn P, Morgan CA. Multiple organ failure related to pantoprazole. Aust N Z J Med 1999; 29(6):833-834.

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