Drug-induced liver injury following positive drug rechallenge

Regulatory Toxicology and Pharmacology

Volumn 54, Issue 1, 2009, Pages 84-90

  Papay, Julie I ^a   Clines, Dawn ^a   Rafi, Rezvan ^a   Yuen, Nancy ^a   Britt, Susan D ^a   Walsh, John S ^a   Hunt, Christine M ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Liver injury; Rechallenge; Retrospective review

Indexed keywords

ABACAVIR; ALANINE AMINOTRANSFERASE; AMOXICILLIN PLUS CLAVULANIC ACID; ASPARTATE AMINOTRANSFERASE; AZATHIOPRINE; BILIRUBIN; COTRIMOXAZOLE; ONDANSETRON; RANITIDINE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CHILD; DATA BASE; DRUG INDUCED DISEASE; DRUG SAFETY; EOSINOPHILIA; FEMALE; FEVER; HUMAN; HYPERBILIRUBINEMIA; INFANT; JAUNDICE; LIVER INJURY; MAJOR CLINICAL STUDY; MALE; PRESCHOOL CHILD; PRIORITY JOURNAL; PROVOCATION TEST; RASH; RISK ASSESSMENT; SCHOOL CHILD;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEPATITIS, TOXIC; HUMANS; JAUNDICE; LIVER FAILURE; MALE; PHARMACEUTICAL PREPARATIONS; PROSPECTIVE STUDIES; RETROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX;

EID: 67349111248     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2009.03.003     Document Type: Article

References (39)

1. Abboud G., Kaplowitz N., Authors F.N., and Kaplowitz N. Drug-induced liver injury. Drug Safety 30 (2007) 277-294
2. Agal S., Baijal R., Pramanik S., et al. Monitoring and management of antituberculosis drug induced hepatotoxicity. Journal of Gastroenterology & Hepatology 20 (2005) 1745-1752
3. Aithal G.P., Rawlins M.D., Day C.P., Authors F.N., Rawlins M.D., and Day C.P. Accuracy of hepatic adverse drug reaction reporting in one English health region. BMJ 319 (1999) 1541
4. Aithal G.P., Rawlins M.D., Day C.P., Authors F.N., Rawlins M.D., and Day C.P. Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions. Journal of Hepatology 33 (2000) 949-952
5. Andrade R.J., Lucena M.I., Fernandez M.C., et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 129 (2005) 512-521
6. Andrade R.J., Lucena M.I., Kaplowitz N., Garcia-Muoz B., Borraz Y., Pachkoria K., et al. Outcome of acute idiosyncratic drug-induced liver injury: long-term follow-up in a hepatotoxicity registry. Hepatology 44 (2006) 1581-1588
7. Andrews E., Dombeck M., Authors F.N., and Dombeck M. The role of scientific evidence of risks and benefits in determining risk management policies for medications. Pharmacoepidemiology and Drug Safety 13 (2004) 599-608
8. Arns P.A., Adedoyin A., DiBisceglie A.M., et al. Mephenytoin disposition and serum bile acids as indices of hepatic function in chronic viral hepatitis. Clinical Pharmacology & Therapeutics 62 (1997) 527-537
9. Becquemont L., Chazouilleres O., Serfaty L., et al. Effect of interferon alpha-ribavirin bitherapy on cytochrome P450 1A2 and 2D6 and N-acetyltransferase-2 activities in patients with chronic active hepatitis C. Clinical Pharmacology & Therapeutics 71 (2002) 488-495
10. Bissell D.M., Gores G.J., Laskin D.L., et al. Drug-induced liver injury: mechanisms and test systems. Hepatology 33 (2001) 1009-1013
11. Bjornsson E., Olsson R., Authors F.N., and Olsson R. Outcome and prognostic markers in severe drug-induced liver disease. Hepatology 42 (2005) 481-489
12. Bohan T.P., Helton E., McDonald I., et al. Effect of L-carnitine treatment for valproate-induced hepatotoxicity. Neurology 45 (2001) 1405-1409
13. Breuskin F., Horsmans Y., Rahier J., et al. Recurrent immuno-allergic hepatitis related to amoxicillin-clavulanic acid. Acta Clinica Belgica 56 (2001) 254-257
14. Castell J.V., and Castell M. Allergic hepatitis induced by drugs. Current Opinion in Allergy and Clinical Immunology 6 (2006) 258-265
15. Chariot P., Drogou I., de Lacroix-Szmania I., et al. Zidovudine-induced mitochondrial disorder with massive liver steatosis, myopathy, lactic acidosis, and mitochondrial DNA depletion. Journal of Hepatology 30 (1999) 156-160
16. Charles E.C., Olson K.L., Sandhoff B.G., et al. Evaluation of cases of severe statin-related transaminitis within a large health maintenance organization. American Journal of Medicine 118 (2005) 618-624
17. Danan G., Benichou C., Authors F.N., and Benichou 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. Journal of Clinical Epidemiology 46 (1993) 1323-1330
18. de Denus S., Spinler S.A., Miller K., et al. Statins and liver toxicity: a meta-analysis. Pharmacotherapy 24 (2004) 584-591 (Review, 49 Refs.)
19. Douglas D.D., Yang R.D., Jensen P., et al. Fatal labetalol-induced hepatic injury. American Journal of Medicine 87 (1989) 235-236
20. FDA Draft Concept Paper, 2007. Drug-Induced Liver Injury: Premarketing Clinical Evaluation, http://www.fda.gov/cder/guidance/7507dft.html.
21. National Institute of Allergy and Infectious Diseases, National Institutes of Health, 2004. Division of AIDS table for grading the severity of adult and pediatric adverse events. Version 1. Available from: http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/PDF/Safety/DAIDSAEGradingTable.pdf.
22. Koch H.K., Gropp A., Oehlert W., Authors F.N., Gropp A., and Oehlert W. Drug-induced liver injury in liver biopsies of the years 1981 and 1983, their prevalence and type of presentation. Pathology, Research & Practice 179 (1985) 469-477
23. Lee W.M., and Authors F.N. Assessing causality in drug-induced liver injury. Journal of Hepatology 33 (2000) 1003-1005
24. Lee W.M., and Authors F.N. Drug-induced hepatotoxicity. New England Journal of Medicine 349 (2003) 474-485
25. Lee W.M., Senior J.R., Authors F.N., and Senior J.R. Recognizing drug-induced liver injury: current problems, possible solutions. Toxicologic Pathology 33 (2005) 155-164
26. Lucena M.I., Camargo R., and Andrade R.J. Comparison of two clinical scales for causality assessment in hepatotoxicity. Hepatology 33 (2001) 123-130
27. Meyboom R.H.B., and Royer R.J. Causality classification at pharmacovigilance centres in the European community. Pharmacoepidemiology and Drug Safety 1 (1992) 87-97
28. Mitchell J.R., Long M.W., Thorgeirsson U.P., et al. Acetylation rates and monthly liver function tests during one year of isoniazid preventive therapy. Chest 68 (1975) 181-190
29. Mushin W.W., Rosen M., Jones E.V., Authors F.N., Rosen M., and Jones E.V. Post-halothane jaundice in relation to previous administration of halothane. British Medical Journal 3 (1971) 18-22
30. Nordberg A., Svensson A.L., Authors F.N., and Svensson A.L. Cholinesterase inhibitors in the treatment of Alzheimer's disease: a comparison of tolerability and pharmacology. Drug Safety 19 (1998) 465-480
31. Rakela J., Mosley J.W., Edwards V.M., et al. A double-blinded, randomized trial of hydrocortisone in acute hepatic failure. The Acute Hepatic Failure Study Group. Digestive Diseases & Sciences 36 (1991) 1223-1228
32. Ramalho H.J., Terra Eg., Cartapatti E., et al. Hepatotoxicity of azathioprine in renal transplant recipients. Transplantation Proceedings 21 (1989) 1716-1717
33. Russo M.W., Galanko J.A., Shrestha R., et al. Liver transplantation for acute liver failure from drug induced liver injury in the United States. Liver Transplantation 10 (2004) 1018-1023
34. Sterneck M., Wiesner R., Ascher N., et al. Azathioprine hepatotoxicity after liver transplantation. Hepatology 14 (1991) 806-810
35. Stricker B.H., Blok A.P., Bronkhorst F.B., Authors F.N., Blok A.P., and Bronkhorst F.B. Glafenine-associated hepatic injury. Analysis of 38 cases and review of the literature. Liver 6 (1986) 63-72
36. Sturgill M.G., Lambert G.H., Authors F.N., and Lambert G.H. Xenobiotic-induced hepatotoxicity: mechanisms of liver injury and methods of monitoring hepatic function. Clinical Chemistry 43 (1997) 1512-1526
37. Verrill M., and Judson I. Jaundice with ondansetron. Lancet 344 (1994) 190-191
38. Watkins P.B., Zimmerman H.J., Knapp M.J., et al. Hepatotoxic effects of tacrine administration in patients with Alzheimer's disease. JAMA 271 (1994) 992-998
39. Zimmerman H.J. Hepatotoxicity. second ed. (1999), Lippincott, Williams, & Wilkins, Philadelphia, PA