Erratum: Flupirtine-induced liver injury - Seven cases from the Berlin case-control surveillance study and review of the German spontaneous adverse drug reaction reporting database (European Journal of Clinical Pharmacology (2014) 70 (453-459) DOI: 10.1007/s00228-013-1631-4);Flupirtine-induced liver injury - Seven cases from the Berlin Case-control Surveillance Study and review of the German spontaneous adverse drug reaction reporting database

European Journal of Clinical Pharmacology

Volumn 70, Issue 4, 2014, Pages 453-459

  Douros, Antonios ^a   Bronder, Elisabeth ^a   Andersohn, Frank ^a   Klimpel, Andreas ^a   Thomae, Michael ^b   Orzechowski, Hans Dieter ^a   Kreutz, Reinhold ^a   Garbe, Edeltraut ^a,c  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b Abteilung Innere Medizin Gastroenterologie   (Germany)

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

Author keywords

Drug safety; Drug induced liver injury; Flupirtine; Hepatotoxicity

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; FLUPIRTINE; AMINOPYRIDINE DERIVATIVE; ANALGESIC AGENT;

ACUTE LIVER FAILURE; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALCOHOLIC FATTY LIVER; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; AUTOIMMUNE HEPATITIS; CASE CONTROL STUDY; CLINICAL ARTICLE; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; EXTRAHEPATIC BILE DUCT OBSTRUCTION; FATIGUE; FEMALE; GERMANY; HUMAN; HYPERBILIRUBINEMIA; JAUNDICE; LEUKOCYTE COUNT; LIVER INJURY; LIVER TOXICITY; LIVER TUMOR; MALE; MEDICAL RECORD REVIEW; MIDDLE AGED; PREVALENCE; PRIORITY JOURNAL; TOXIC HEPATITIS; TREATMENT DURATION; AGED; CASE REPORT; DRUG-INDUCED LIVER INJURY;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AMINOPYRIDINES; ANALGESICS; BERLIN; CASE-CONTROL STUDIES; DRUG-INDUCED LIVER INJURY; FEMALE; GERMANY; HUMANS; MALE; MIDDLE AGED;

EID: 84896490129     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-015-1810-6     Document Type: Erratum

References (31)

1. Devulder J (2010) Flupirtine in Pain Management Pharmacological Properties and Clinical Use. Cns Drugs 24(10):867-881
2. Flupirtine - German prescribing information. http://www.fachinfo.de/ viewFI?FINR=001179&RL=Katadolon%26reg%3B%20Hartkapseln . 1-5-2013. 24-7-2013.
3. Puls F, Agne C, Klein F, Koch M, Rifai K, Manns MP et al (2011) Pathology of flupirtine-induced liver injury: a histological and clinical study of six cases. Virchows Arch 458(6):709-716
4. Treudler R, Pohle K, Simon JC (2011) Flupirtine is a safe alternative drug in patients with hypersensitivity to NSAIDs. Eur J Clin Pharmacol 67(9):961-963
5. Klawe C, Maschke M (2009) Flupirtine: pharmacology and clinical applications of a nonopioid analgesic and potentially neuroprotective compound. Expert Opin Pharmacother 10(9):1495-1500
6. Michel MC, Radziszewski P, Falconer C, Marschall-Kehrel D, Blot K. Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years. Br J Clin Pharmacol 2011.
7. Klein F, Glanemann M, Rudolph B, Seehofer D, Neuhaus P (2011) Flupirtine-induced hepatic failure requiring orthotopic liver transplant. Exp Clin Transplant 9(4):270-272
8. PRAC recommends restricting the use of flupirtine-containing medicines. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/ Flupirtine-containing-medicines/human-referral-prac-000019.jsp&mid= WC0b01ac05805c516f. 14-6-2013. 18-6-2013.
9. Andersohn F, Bronder E, Klimpel A, Garbe E (2004) Proportion of drug-related serious rare blood dyscrasias: Estimates from the Berlin case-control surveillance study. Am J Hematol 77(3):316-318 (Pubitemid 39430715)
10. Garbe E, Andersohn F, Bronder E, Klimpel A, Thomae M, Schrezenmeier H et al (2011) Drug induced immune haemolytic anaemia in the Berlin Case-control Surveillance Study. Br J Haematol 154(5):644-653
11. Garbe E, Andersohn F, Bronder E, Salama A, Klimpel A, ThomaeM et al. Drug-induced immune thrombocytopaenia: results from the Berlin Case-control Surveillance Study. Eur J Clin Pharmacol 2011.
12. Danan G, Benichou C (1993) Causality Assessment of Adverse Reactions to Drugs.1. A Novel Method Based on the Conclusions of International Consensus Meetings-Application to Drug-Induced Liver Injuries. J Clin Epidemiol 46(11):1323-1330 (Pubitemid 23333873)
13. Benichou C (1990) Criteria of Drug-Induced Liver Disorders-Report of An International Consensus Meeting. J Hepatol 11(2):272-276
14. Brown EG, Wood L, Wood S (1999) The medical dictionary for regulatory activities (MedDRA). Drug Saf 20(2):109-117 (Pubitemid 29101275)
15. Chilet-Rosell E, Ruiz-Cantero MT, Saez JF, Alvarez-Dardet C (2013) Inequality in analgesic prescription in Spain. A gender development issue. Gac Sanit 27(2):135-142
16. Coca V, Schröder H (2012) Arzneimittelverordnungen nach Alter und Geschlecht. In: Schwabe U, Paffrath D(eds) Arzneiverordnungs-Report 2012. Springer, Berlin
17. Leresche L (2011) Defining gender disparities in pain management. Clin Orthop Relat Res 469(7):1871-1877
18. Andrade RJ, Lucena MI, Fernandez MC, Pelaez G, Pachkoria K, Garcia-Ruiz E et al (2005) Drug-induced liver injury: An analysis of 461 incidences submitted to the Spanish Registry over a 10-year period. Gastroenterology 129(2):512-521 (Pubitemid 41096639)
19. Hussaini SH, Farrington EA (2007) Idiosyncratic drug-induced liver injury: an overview. Expert Opin Drug Saf 6(6):673-684 (Pubitemid 351308279)
20. Anderson N, Borlak J (2011) Correlation versus causation? Pharmacovigilance of the analgesic flupirtine exemplifies the need for refined spontaneous ADR reporting. PLoS One 6(10):e25221
21. Leberschäden im Zusammenhang mit Flupirtin. http://www.akdae.de/ Arzneimittelsicherheit/DSM/Archiv/2013-13.html. 5-3-2013. 8-4-2013.
22. Review of flupirtine-containing medicines started. http://www.ema.europa. eu/ema/index.jsp?curl=pages/medicines/human/referrals/Flupirtine-containing- medicines/human-referral-prac-000019.jsp&mid=WC0b01ac05805c516f. 7-3-2013. 8-4-2013.
23. Guideline on good pharmacovigilance practices:Module VIII-Post- authorisation safety studies. http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2012/06/WC500129137.pdf. 25-4-2013. 27-11-2013.
24. Böger RH, Schmidt G (2005) Analgetika. In: Schwabe U, Paffrath D (eds) Arzneiverordnungs-Report 2005. Springer, Berlin
25. Böger RH, Schmidt G (2006) Analgetika. In: Schwabe U, Paffrath D (eds) Arzneiverordnungs-Report 2006. Springer, Berlin
26. Böger RH, Schmidt G (2007) Analgetika. In: Schwabe U, Paffrath D (eds) Arzneiverordnungs-Report 2007. Springer, Berlin
27. Böger RH, Schmidt G (2008) Analgetika. In: Schwabe U, Paffrath D (eds) Arzneiverordnungs-Report 2008. Springer, Berlin
28. Böger RH, Schmidt G (2009) Analgetika. In: Schwabe U, Paffrath D (eds) Arzneiverordnungs-Report 2009. Springer, Berlin
29. Böger RH, Schmidt G (2010) Analgetika. In: Schwabe U, Paffrath D (eds) Arzneiverordnungs-Report 2010. Springer, Berlin
30. Böger RH, Schmidt G (2011) Analgetika. In: Schwabe U, Paffrath D (eds) Arzneiverordnungs-Report 2011. Springer, Berlin
31. Böger RH, Schmidt G (2012) Analgetika. In: Schwabe U, Paffrath D (eds) Arzneiverordnungs-Report 2012. Springer, Berlin