A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs

British Journal of Clinical Pharmacology

Volumn 48, Issue 6, 1999, Pages 847-852

  Garcia Rodriguez L A ^a   Duque, A ^b   Castellsague, Jordi ^b   Perez Gutthann S ^b   Stricker, B H Ch ^c  

^a Ctro Espanol de Metrologia   (Spain)

^b Global Epidemiology   (Spain)

^c ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

Author keywords

Acute liver injury; Epidemiology; General practice research database; Observational studies; Oral antifungals

Indexed keywords

ANTIFUNGAL AGENT; FLUCONAZOLE; GRISEOFULVIN; ITRACONAZOLE; KETOCONAZOLE; TERBINAFINE;

ADULT; AGED; ARTICLE; COHORT ANALYSIS; DATA BASE; DRUG USE; FEMALE; HUMAN; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MYCOSIS; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RISK ASSESSMENT; UNITED KINGDOM;

ACUTE DISEASE; ADULT; AGED; ANTIFUNGAL AGENTS; COHORT STUDIES; FEMALE; GREAT BRITAIN; HEPATITIS, TOXIC; HUMANS; KETOCONAZOLE; MALE; MIDDLE AGED; RISK;

EID: 0032785870     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2125.1999.00095.x     Document Type: Article

References (28)

1. 1 Hay RJ. Risk/benefit ratio of modern antifungal therapy. Focus on hepatic reactions. J Am Acad Dermatol 1993; 29: s50-s4.
2. 2 Reddy KR, Schiff ER. Hepatotoxicity of antimicrobial, antifungal, and antiparasitic agents. Gatroenterol Clinics North Am 1995; 24: 923-926.
3. 3 Lewis JH, Zimmerman HJ, Benson GD, Ishak KG. Hepatic injury associated with ketoconazole therapy. Analysis of 33 cases. Gastroenterology 1984; 86: 503-513.
4. 4 Stricker BHCh, Blok APR, Bronkhorst FB, Van Parys GE, Desmet VJ. Ketoconazole-associated hepatic injury. A clinicopathological study of 55 cases. J Hepatol 1986; 3: 399-406.
5. 5 Lake-Bakaar G, Scheuer PJ, Sherlock S. Hepatic reactions associated with ketoconazole in the United Kingdom. Br Med J 1987; 294: 419-422.
6. 6 Chien RN, Yang LJ, Lin PY, Liaw YF. Hepatic injury during ketoconazole therapy in patients with onychomycosis: a controlled cohort study. Hepatology 1997; 25: 103-107.
7. 7 Chiprut RO, Viteri A, Jamroz C, Dyck WP. Intrahepatic cholestasis after griseofulvin administration. Gastroenterology 1976; 70: 1141-1143.
8. 8 Breinstrup AH, Sogaard-Anderson J. Cholestasis intrahepatica efter griseofulvinbehandling. Ugeskr Laeger 1966; 128: 145-147.
9. 9 Gallardo-Quesada S, Luelmo-Aguilar J, Guanyabens-Calvet C. Hepatotoxicity associated with itraconazole. Int J Dermatol 1995; 34: 589.
10. 10 Lavrijsen APM, Balmus KJ, Nugteren Huying WM, Roldaan AC, van't Wout JW, Stricker BHCh. Hepatic injury associated with itraconazole. Lancet 1992; 340: 251-252.
11. 11 Lowe G, Green C, Jennings P. Hepatitis associated with terbinafine treatment. Br Med J 1993; 306: 248.
12. 12 Boldewijn OY, Ottervanger JP, Mostart CM, Janssens AR, Calame J, Jonkers GJ. Hepatitis attributed to the use of terbinafine. Ned Tijdschr Geneeskd 1996; 140: 669-672.
13. 13 van't Wout JW, Herrmann WA, de Vnes RA, Stricker BHCh. Terbinafine-associated hepatic injury. J Hepatol 1994; 21: 115-117.
14. 14 Lazaros GA, Papatheodoridis GV, Delladetsima JK, Tassopoulos NC. Terbinafine-induced cholestatic liver disease. J Hepatol 1996; 24: 753-756.
15. 15 Gearhart MO. Worsening of liver function with fluconazole and review of azole antifungal hepatotoxicity. Ann Pharmacother 1994; 28: 1177-1181.
16. 16 Franklin JM, Ellas E, Hirsch C. Fluconazole induced jaundice. Lancet 1990; 336: 565.
17. 17 Munoz P, Moreno S, Berenguer J, Bernaldo de Quiros JL, Bouza E. Fluconazole related hepatotoxicity in patients witch acquired immunodeficiency syndrome. Arch Intern Med 1991; 151: 1020-1021.
18. 18 Trujillo MA, Galgiani JN, Sampllner RF. Evaluation of hepatic injury arising during fluconazole therapy. Arch Intern Med 1994; 154: 102-104.
19. 19 Wells C, Lever AM. Dose-dependent fluconazole hepatotoxicity proved on biopsy and rechallenge. J Infect 1992; 24: 111-112.
20. 20 Jacobson MA, Hanks DK, Ferrell LD. Fatal acute hepatic necrosis due to fluconazole. Am J Med 1994; 96: 188-190.
21. 21 Hall M, Monka C, Krupp P, O'Sullivan D. Safety of oral terbinafme: results of a postmarketing surveillance study in 25884 patients. Arch Dermatol 1997; 133: 1213-1219.
22. 22 García Rodríguez LA, Pérez Gutthann S. Use of the UK General Practice Research Database for pharmacoepidemiology. Br J Clin Pharmacol 1998; 45: 419-425.
23. 23 Jick H, Jick SS, Derby LE. Validation of information recorded on general practitioner based computerised data resource in the United Kingdom. Br Med J 1991; 302: 766-768.
24. 24 García Rodríguez LA, Ruigómez A, Jick H. A review of epidemiologic research on drug-induced acute liver injury using the General Practice Research Database in the United Kingdom. Pharmacotherapy 1997; 17: 721-728.
25. 25 Report of an international consensus meeting, criteria of drug-induced liver disorders. J Hepatol 1990; 11: 272-276.
26. 26 Stricker BH, ed. Drug-induced hepatic injury. Amsterdam, The Netherlands: Elsevier Science Publishers, 1992.
27. 27 Martin D, Austin H. An efficient program for computing conditional maximum likelihood and exact confidence limits for a common odds ratio. Epidemiology 1991; 2: 359-362.
28. 28 Park BK, Kitteringham NR, Pirmohamed M, et al. Relevance of induction of human drug-metabolizing enzymes: pharmacological and toxicological implications. Br J Clin Pharmacol 1996; 41: 477-491.