Drug-related hepatotoxicity.

Given its rarity, drug-related hepatotoxicity may not be seen during the initial clinical trials of a new medication. After approval, when many more patients are exposed, toxic effects that are very infrequent may emerge. This review explains the difficulties in identifying the cause of hepatotoxic effects in such situations and provides clinical guidance with regard to the detection, evaluation, and possible prevention of drug-related hepatotoxicity.

[1]  P. Watkins,et al.  Hepatic dysfunction associated with troglitazone. , 1998, The New England journal of medicine.

[2]  E. Björnsson,et al.  Outcome and prognostic markers in severe drug‐induced liver disease , 2005, Hepatology.

[3]  T. Bohan,et al.  Effect of l-carnitine treatment for valproate-induced hepatotoxicity , 2001, Neurology.

[4]  Joe Kesterson,et al.  Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity. , 2004, Gastroenterology.

[5]  G. Danan,et al.  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. , 1993, Journal of clinical epidemiology.

[6]  M. Manns,et al.  Identification and Characterization of a Functional TATA Box Polymorphism of the UDP Glucuronosyltransferase 1A7 Gene , 2005, Molecular Pharmacology.

[7]  F. Schaffner,et al.  Nonalcoholic fatty liver disease. , 1986, Progress in liver diseases.

[8]  D. Davidson.  Association of acetaminophen hepatotoxicity with fasting and ethanol use , 1995 .

[9]  V. Desmet.  Vanishing bile duct syndrome in drug-induced liver disease. , 1997, Journal of hepatology.

[10]  K. Tolman.  The liver and lovastatin. , 2002, The American journal of cardiology.

[11]  R. Victorino,et al.  Development and validation of a clinical scale for the diagnosis of drug‐induced hepatitis , 1997, Hepatology.

[12]  P. Hillon,et al.  Incidence of drug‐induced hepatic injuries: A French population‐based study , 2002, Hepatology.

[13]  R. Woosley,et al.  Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin , 1992, Clinical pharmacology and therapeutics.

[14]  J. Emparanza,et al.  [The prevalence of hepatitis C virus infection]. , 1998, Gastroenterologia y hepatologia.

[15]  D. Larrey,et al.  Genetic predisposition to drug-induced hepatotoxicity. , 1997, Journal of hepatology.

[16]  J. Critchley,et al.  The treatment of acetaminophen poisoning. , 1983, Annual review of pharmacology and toxicology.

[17]  D. Pessayre,et al.  Mitochondria in Steatohepatitis , 2001, Seminars in liver disease.

[18]  S. Knowles,et al.  Idiosyncratic drug reactions: the reactive metabolite syndromes , 2000, The Lancet.

[19]  F. Chang,et al.  Polymorphism of the N‐acetyltransferase 2 gene as a susceptibility risk factor for antituberculosis drug–induced hepatitis , 2002, Hepatology.

[20]  C. Bénichou.  Criteria of drug-induced liver disorders. Report of an international consensus meeting. , 1990, Journal of hepatology.

[21]  H. Zimmerman,et al.  Hepatotoxicity: The adverse effects of drugs and other chemicals on the liver , 1978 .

[22]  William M. Lee,et al.  Acetaminophen‐induced acute liver failure: Results of a United States multicenter, prospective study , 2005, Hepatology.

[23]  Jeanne M Clark,et al.  Defining nonalcoholic fatty liver disease: implications for epidemiologic studies. , 2003, Gastroenterology.

[24]  P. Watkins.  Insight into hepatotoxicity: The troglitazone experience , 2005, Hepatology.

[25]  Inda,et al.  The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. , 1999, The New England journal of medicine.

[26]  N. Kaplowitz.  Causality assessment versus guilt‐by‐association in drug hepatotoxicity , 2001, Hepatology.

[27]  F. Guengerich,et al.  Oxidation of the antihistaminic drug terfenadine in human liver microsomes. Role of cytochrome P-450 3A(4) in N-dealkylation and C-hydroxylation. , 1993, Drug metabolism and disposition: the biological fate of chemicals.

[28]  J. Hoofnagle,et al.  Drug‐induced liver injury network (DILIN) , 2004, Hepatology.

[29]  草野 浩治,et al.  AASLD position paper: the management of acute liver failure (特集 救急診療ガイドライン) -- (海外のガイドライン) , 2008 .

[30]  W. Ray,et al.  Population-based studies of adverse drug effects. , 2003, The New England journal of medicine.

[31]  N. Marcon,et al.  Are Patients With Elevated Liver Tests at Increased Risk of Drug-Induced Liver Injury? , 2004 .

[32]  B. Smith,et al.  Severe irinotecan-induced toxicities in a patient with uridine diphosphate glucuronosyltransferase 1A1 polymorphism. , 2005, Clinical colorectal cancer.

[33]  N. Kaplowitz,et al.  Drug-Induced Liver Injury , 2004, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[34]  Luis Rodrigo,et al.  Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. , 2005, Gastroenterology.

[35]  N. Kaplowitz.  Biochemical and Cellular Mechanisms of Toxic Liver Injury , 2002, Seminars in liver disease.

[36]  David A. Kessler,et al.  Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems. , 1994 .

[37]  A. Satterfield,et al.  TREATMENT , 1924, California and western medicine.

[38]  A. Flahault,et al.  Causality assessment of adverse reactions to drugs--II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge. , 1993, Journal of clinical epidemiology.

[39]  J. Boyer,et al.  Molecular pathogenesis of cholestasis. , 2012, The New England journal of medicine.

[40]  S. Buskin,et al.  Hepatotoxicity associated with isoniazid preventive therapy: a 7-year survey from a public health tuberculosis clinic. , 1999, JAMA.

[41]  N. Mcintyre,et al.  Biochemical Investigations in the Management of Liver Disease , 1992 .

[42]  J C Reed,et al.  Apoptosis-regulating proteins as targets for drug discovery. , 2001, Trends in molecular medicine.

[43]  R. Weinshilboum.  Inheritance and drug response. , 2003, The New England journal of medicine.

[44]  D. Pessayre,et al.  Plasma membrane cytochromes P450 as neoantigens and autoimmune targets in drug-induced hepatitis. , 1997, Journal of hepatology.

[45]  K. Kaita,et al.  Fatty Infiltration of Liver in Hyperlipidemic Patients , 2000, Digestive Diseases and Sciences.

[46]  P. Beaune,et al.  Human anti-endoplasmic reticulum autoantibodies appearing in a drug-induced hepatitis are directed against a human liver cytochrome P-450 that hydroxylates the drug. , 1987, Proceedings of the National Academy of Sciences of the United States of America.

[47]  Howard L McLeod,et al.  Pharmacogenomics--drug disposition, drug targets, and side effects. , 2003, The New England journal of medicine.

[48]  J. Vandenbroucke.  In Defense of Case Reports and Case Series , 2001, Annals of Internal Medicine.

[49]  W. M. Lee,et al.  Drug-induced hepatotoxicity. , 1995, The New England journal of medicine.

[50]  J. Senior,et al.  Troglitazone-induced liver failure: a case study. , 2003, The American journal of medicine.

[51]  C. Degott,et al.  Drug‐induced prolonged cholestasis in adults: A histological semiquantitative study demonstrating progressive ductopenia , 1992, Hepatology.

[52]  C. Codina,et al.  The use of evidence in pharmacovigilance. Case reports as the reference source for drug withdrawals. , 2001, European journal of clinical pharmacology.

[53]  R. Andrade,et al.  Causality assessment in drug-induced hepatotoxicity , 2004, Expert opinion on drug safety.

[54]  J. M. Calvo Romero,et al.  Gastric adenocarcinoma and kidney transplantation , 1998 .

[55]  P. Watkins,et al.  Hepatotoxic effects of tacrine administration in patients with Alzheimer's disease. , 1994, JAMA.

[56]  R. Andrade,et al.  Comparison of two clinical scales for causality assessment in hepatotoxicity , 2001, Hepatology.

[57]  William M. Lee,et al.  Recognizing Drug-Induced Liver Injury: Current Problems, Possible Solutions , 2005, Toxicologic pathology.

[58]  D. Larrey.  Epidemiology and Individual Susceptibility to Adverse Drug Reactions Affecting the Liver , 2002, Seminars in liver disease.