Drug-induced liver injury: Results from the hospital-based Berlin Case-Control Surveillance Study

British Journal of Clinical Pharmacology

Volumn 79, Issue 6, 2015, Pages 988-999

  Douros, Antonios ^a,b   Bronder, Elisabeth ^a   Andersohn, Frank ^a   Klimpel, Andreas ^a   Thomae, Michael ^c   Sarganas, Giselle ^a   Kreutz, Reinhold ^a   Garbe, Edeltraut ^a,b  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b LEIBNIZ INSTITUTE FOR PREVENTION RESEARCH AND EPIDEMIOLOGY BIPS   (Germany)

^c Abteilung Innere Medizin Gastroenterologie   (Germany)

Author keywords

drug safety; hepatotoxicity; pharmacovigilance

Indexed keywords

ACETYLSALICYLIC ACID; ACICLOVIR; AMIODARONE; AMITRIPTYLINE; ANGIOTENSIN 2 RECEPTOR ANTAGONIST; ANTIDEPRESSANT AGENT; ATYPICAL ANTIPSYCHOTIC AGENT; BETA LACTAM ANTIBIOTIC; BIPERIDEN; CIPROFLOXACIN; CITALOPRAM; CLARITHROMYCIN; CLOZAPINE; DEXAMETHASONE; DIPYRONE; ENOXAPARIN; FLUPIRTINE; GLUCOCORTICOID; IBUPROFEN; IRBESARTAN; LISINOPRIL; MACROLIDE; MAGNESIUM; METOCLOPRAMIDE; PANTOPRAZOLE; PHENPROCOUMON; QUINOLONE DERIVATIVE; RIFAMPICIN; UNINDEXED DRUG; VALERIAN; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BIOLOGICAL MARKER;

ACUTE LIVER FAILURE; ADULT; ARTICLE; CONTROLLED STUDY; COUNCIL FOR INTERNATIONAL ORGANIZATIONS AND MEDICAL SCIENCES SCALE; DRUG EXPOSURE; FEMALE; GERMANY; HOSPITAL; HUMAN; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PRIORITY JOURNAL; RATING SCALE; RISK ASSESSMENT; TOXIC HEPATITIS; AGED; BLOOD; CASE CONTROL STUDY; CHEMICAL AND DRUG INDUCED LIVER INJURY; CHEMICALLY INDUCED; CHI SQUARE DISTRIBUTION; DRUG EFFECTS; LIVER; LIVER FAILURE, ACUTE; LIVER FUNCTION TEST; METABOLISM; ODDS RATIO; RISK FACTOR; STATISTICAL MODEL; TIME FACTOR;

ADULT; AGED; ALANINE TRANSAMINASE; ASPARTATE AMINOTRANSFERASES; BERLIN; BILIRUBIN; BIOMARKERS; CASE-CONTROL STUDIES; CHEMICAL AND DRUG INDUCED LIVER INJURY; CHI-SQUARE DISTRIBUTION; FEMALE; HOSPITALS; HUMANS; LIVER; LIVER FAILURE, ACUTE; LIVER FUNCTION TESTS; LOGISTIC MODELS; MALE; MIDDLE AGED; ODDS RATIO; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS;

EID: 84930004988     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12565     Document Type: Article

References (57)

1. Hayashi PH, Fontana RJ,. Clinical features, diagnosis, and natural history of drug-induced liver injury. Semin Liver Dis 2014; 34: 134-144.
2. Reuben A, Koch DG, Lee WM,. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology 2010; 52: 2065-2076.
3. Benichou C,. Criteria of drug-induced liver disorders-report of an international consensus meeting. J Hepatol 1990; 11: 272-276.
4. Ostapowicz G, Fontana RJ, Schiodt FV, Larson A, Davern TJ, Han SH, McCashland TM, Shakil AO, Hay JE, Hynan L, Crippin JS, Blei AT, Samuel G, Reisch J, Lee WM,. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med 2002; 137: 947-954.
5. Hussaini SH, Farrington EA,. Idiosyncratic drug-induced liver injury: an overview. Expert Opin Drug Saf 2007; 6: 673-684.
6. Edwards IR, Aronson JK,. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356: 1255-1259.
7. de Abajo FJ, Montero D, Madurga M, Garcia Rodriguez LA,. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br J Clin Pharmacol 2004; 58: 71-80.
8. Garcia Rodriguez LA, Wallander MA, Stricker BH,. The risk of acute liver injury associated with cimetidine and other acid-suppressing anti-ulcer drugs. Br J Clin Pharmacol 1997; 43: 183-188.
9. Garbe E, Andersohn F, Bronder E, Klimpel A, Thomae M, Schrezenmeier H, Hildebrandt M, Spath-Schwalbe E, Gruneisen A, Mayer B, Salama A, Kurtal H,. Drug induced immune haemolytic anaemia in the Berlin Case-Control Surveillance Study. Br J Haematol 2011; 154: 644-653.
10. Garbe E, Andersohn F, Bronder E, Salama A, Klimpel A, Thomae M, Schrezenmeier H, Hildebrandt M, Spath-Schwalbe E, Gruneisen A, Meyer O, Kurtal H,. Drug-induced immune thrombocytopaenia: results from the Berlin Case-Control Surveillance Study. Eur J Clin Pharmacol 2012; 68: 821-832.
11. Grimes DA, Schulz KF,. Compared to what? Finding controls for case-control studies. Lancet 2005; 365: 1429-1433.
12. Teschke R, Wolff A, Frenzel C, Schwarzenboeck A, Schulze J, Eickhoff A,. Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment. World J Hepatol 2014; 6: 17-32.
13. The Anatomical Therapeutic Chemical Classification System with Defined Daily Doses (ATC/DDD). Available at http://www.who.int/classifications/atcddd/en (last accessed 1 January 2003). 24 February 2012.
14. Dicker RC,. Designing studies in the field. In: Field Epidemiology, 2nd edn. ed., Gregg MB,. New York: Oxford University Press, Inc., 2002; 122.
15. Schimanski CC, Burg J, Mohler M, Hohler T, Kanzler S, Otto G, Galle PR, Lohse AW,. Phenprocoumon-induced liver disease ranges from mild acute hepatitis to (sub-) acute liver failure. J Hepatol 2004; 41: 67-74.
16. Lewis JH, Ranard RC, Caruso A, Jackson LK, Mullick F, Ishak KG, Seeff LB, Zimmerman HJ,. Amiodarone hepatotoxicity-prevalence and clinicopathologic correlations among 104 patients. Hepatology 1989; 9: 679-685.
17. Kao WY, Su CW, Huang YS, Chou YC, Chen YC, Chung WH, Hou MC, Lin HC, Lee FY, Wu JC,. Risk of oral antifungal agent-induced liver injury in Taiwanese. Br J Clin Pharmacol 2014; 77: 180-189.
18. Tietz A, Heim MH, Eriksson U, Marsch S, Terracciano L, Krahenbuhl S,. Fulminant liver failure associated with clarithromycin. Ann Pharmacother 2003; 37: 57-60.
19. Tostmann A, Boeree MJ, Aarnoutse RE, de Lange WCM, van der Ven AJAM, Dekhuijzen R,. Antituberculosis drug-induced hepatotoxicity: concise up-to-date review. J Gastroenterol Hepatol 2008; 23: 192-202.
20. Orman ES, Conjeevaram HS, Vuppalanchi R, Freston JW, Rochon J, Kleiner DE, Hayashi PH,. Clinical and histopathologic features of fluoroquinolone-induced liver injury. Clin Gastroenterol Hepatol 2011; 9: 517-523.
21. Schreiber AJ, Simon FR,. Estrogen-induced cholestasis: clues to pathogenesis and treatment. Hepatology 1983; 3: 607-613.
22. Khokhar OS, Lewis JH,. Hepatotoxicity of agents used in the management of inflammatory bowel disease. Dig Dis 2010; 28: 508-518.
23. Yeung E, Wong FS, Wanless IR, Shiota K, Guindi M, Joshi S, Gardiner G,. Ramipril-associated hepatotoxicity. Arch Pathol Lab Med 2003; 127: 1493-1497.
24. Andrade RJ, Lucena MI, Fernandez MC, Vega JL, Garcia-Cortes M, Casado M, Guerrero-Sanchez E, Pulido-Fernandez F,. Cholestatic hepatitis related to use of irbesartan: a case report and a literature review of angiotensin II antagonist-associated hepatotoxicity. Eur J Gastroenterol Hepatol 2002; 14: 887-890.
25. Koklu S, Yuksel O, Yolcu OF, Arhan M, Altiparmak E,. Cholestatic attack due to ampicillin and cross-reactivity to cefuroxime. Ann Pharmacother 2004; 38: 1539-1540.
26. Voican CS, Corruble E, Naveau S, Perlemuter G,. Antidepressant-induced liver injury: a review for clinicians. Am J Psychiatry 2014; 171: 404-415.
27. Brown CA, Telio S, Warnock CA, Wong AH,. Clozapine toxicity and hepatitis. J Clin Psychopharmacol 2013; 33: 570-571.
28. Ozcanli T, Erdogan A, Ozdemir S, Onen B, Ozmen M, Doksat K, Sonsuz A,. Severe liver enzyme elevations after three years of olanzapine treatment: a case report and review of olanzapine associated hepatotoxicity. Prog Neuropsychopharmacol Biol Psychiatry 2006; 30: 1163-1166.
29. Paulzen M, Orfanos S, Grunder G,. Remission of drug-induced hepatitis after switching from risperidone to paliperidone. Am J Psychiatry 2010; 167: 351-352.
30. Mouradian-Stamatiadis L, Dumortier G, Januel D, Delmas BA, Cabaret W,. Liver function tests during treatment with antipsychotic drugs: a case series of 23 patients. Prog Neuropsychopharmacol Biol Psychiatry 2002; 26: 1409-1411.
31. PRAC recommends restricting the use of flupirtine-containing medicines. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Flupirtine-containing-medicines/human-referral-prac-000019.jsp&mid=WC0b01ac05805c516f (last accessed 14 June 2013). 18 June 2013.
32. Douros A, Bronder E, Andersohn F, Klimpel A, Thomae M, Orzechowski HD, Kreutz R, Garbe E,. Flupirtine-induced liver injury-Seven cases from the Berlin Case-Control Surveillance Study and review of the German spontaneous adverse drug reaction reporting database. Eur J Clin Pharmacol 2014; 70: 453-459.
33. Schlienger RG, Keller MJ, Krahenbuhl S,. Tolterodine-associated acute mixed liver injury. Ann Pharmacother 2002; 36: 817-819.
34. Khurana S, Jadeja R, Twaddell W, Cheng K, Rachakonda V, Saxena N, Raufman JP,. Effects of modulating M3 muscarinic receptor activity on azoxymethane-induced liver injury in mice. Biochem Pharmacol 2013; 86: 329-338.
35. Craig DG, Bates CM, Davidson JS, Martin KG, Hayes PC, Simpson KJ,. Staggered overdose pattern and delay to hospital presentation are associated with adverse outcomes following paracetamol-induced hepatotoxicity. Br J Clin Pharmacol 2012; 73: 285-294.
36. Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E, Hynan LS, Reisch JS, Schiodt FV, Ostapowicz G, Shakil AO, Lee WM,. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology 2005; 42: 1364-1372.
37. Hadem J, Tacke F, Bruns T, Langgartner J, Strnad P, Denk GU, Fikatas P, Manns MP, Hofmann WP, Gerken G, Grunhage F, Umgelter A, Trautwein C, Canbay A,. Etiologies and outcomes of acute liver failure in Germany. Clin Gastroenterol Hepatol 2012; 10: 664-669.
38. Protocol of the 60th Meeting of the Expert Advisory Committee for Prescription-Only Issues. Available at http://www.bfarm.de/DE/Pharmakovigilanz/Verschreibungspflicht/Protokolle/60Sitzung/top6.html?nn=1011772 (last accessed 15 January 2008). 9 May 2012.
39. Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, Seeff LB, Serrano J, Sherker AH, Stolz A, Talwalkar J, Vega M, Vuppalanchi R,. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology 2014; 60: 1399-1408.
40. Andrade RJ, Lucena MI, Fernandez MC, Pelaez G, Pachkoria K, Garcia-Ruiz E, Garcia-Munoz B, Gonzalez-Grande R, Pizarro A, Duran JA, Jimenez M, Rodrigo L, Romero-Gomez M, Navarro JM, Planas R, Costa J, Borras A, Soler A, Salmeron J, Martin-Vivaldi R,. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish Registry over a 10-year period. Gastroenterology 2005; 129: 512-521.
41. Bjornsson ES, Bergmann OM, Bjornsson HK, Kvaran RB, Olafsson S,. Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology 2013; 144: 1419-1425.
42. Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J,. Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008; 135: 1924-1934, 1934.
43. De Valle MB, Av KV, Alem N, Olsson R, Bjornsson E,. Drug-induced liver injury in a Swedish University hospital out-patient hepatology clinic. Aliment Pharmacol Ther 2006; 24: 1187-1195.
44. Al-Homaidhi H, Abdel-Haq NM, El-Baba M, Asmar BI,. Severe hepatitis associated with oxacillin therapy. South Med J 2002; 95: 650-652.
45. Lee WM, Stravitz RT, Larson AM,. Introduction to the revised American Association for the Study of Liver Diseases Position Paper on acute liver failure 2011. Hepatology 2012; 55: 965-967.
46. Aithal GP, Rawlins MD, Day CP,. Accuracy of hepatic adverse drug reaction reporting in one English health region. BMJ 1999; 319: 1541.
47. Teschke R, Frenzel C, Wolff A, Eickhoff A, Schulze J,. Drug induced liver injury: accuracy of diagnosis in published reports. Ann Hepatol 2014; 13: 248-255.
48. Benichou 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: 1331-1336.
49. Aithal GP, Watkins PB, Andrade RJ, Larrey D, Molokhia M, Takikawa H, Hunt CM, Wilke RA, Avigan M, Kaplowitz N, Bjornsson E, Daly AK,. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther 2011; 89: 806-815.
50. Garcia-Cortes M, Stephens C, Lucena MI, Fernandez-Castaner A, Andrade RJ,. Causality assessment methods in drug induced liver injury: strengths and weaknesses. J Hepatol 2011; 55: 683-691.
51. Schulze J, Glass X,. Statin hepatotoxicity and the dilemma of causality in rare hepatic adverse drug reactions. J Hepatol 2012; 57: 702-703.
52. Stammschulte T, Gundert-Remy U,. Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: was causality adequately ascertained? Regul Toxicol Pharmacol 2012; 64: 342-344.
53. Teschke R, Frenzel C, Schulze J, Eickhoff A,. Suspected herbal hepatotoxicity: the pharmacovigilance dilemma with disputed and obsolete evaluation methods. Regul Toxicol Pharmacol 2012; 64: 343-344.
54. Teschke R, Frenzel C, Wolff A, Herzog J, Glass X, Schulze J, Eickhoff A,. Initially purported hepatotoxicity by Pelargonium sidoides: the dilemma of pharmacovigilance and proposals for improvements. Ann Hepatol 2012; 11: 500-512.
55. Teschke R, Eickhoff A, Schulze J,. Drug- and herb-induced liver injury in clinical and translational hepatology: causality assessment methods, quo vadis? J Clin Translat Hepatol 2013; 1: 59-74.
56. Teschke R, Frenzel C, Schulze J, Eickhoff A,. Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: was causality adequately ascertained? Regul Toxicol Pharmacol 2012; 63: 1-9.
57. Wacholder S, McLaughlin JK, Silverman DT, Mandel JS,. Selection of controls in case-control studies. I. Principles. Am J Epidemiol 1992; 135: 1019-1028.