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Volumn 34, Issue 3, 2014, Pages 327-330

Hepatotoxicity related to agomelatine and other new antidepressants: A case/noncase approach with information from the portuguese, French, Spanish, and Italian pharmacovigilance systems

Author keywords

antidepressants; case noncase approach; hepatotoxicity; pharmacovigilance databases

Indexed keywords

AGOMELATINE; AMFEBUTAMONE; AMINEPTINE; ANTIDEPRESSANT AGENT; CITALOPRAM; DULOXETINE; ESCITALOPRAM; FLUOXETINE; FLUVOXAMINE; MIANSERIN; MIRTAZAPINE; NEFAZODONE; PAROXETINE; REBOXETINE; SERTRALINE; TIANEPTINE; TRAZODONE; VENLAFAXINE; ACETAMIDE DERIVATIVE;

EID: 84900483011     PISSN: 02710749     EISSN: 1533712X     Source Type: Journal    
DOI: 10.1097/JCP.0000000000000094     Document Type: Article
Times cited : (28)

References (28)
  • 1
    • 0036569927 scopus 로고    scopus 로고
    • Safety of newly approved drugs: Implications for prescribing
    • Temple RJ, Himmel MH. Safety of newly approved drugs: implications for prescribing. JAMA. 2002;287:2273-2275.
    • (2002) JAMA. , vol.287 , pp. 2273-2275
    • Temple, R.J.1    Himmel, M.H.2
  • 2
    • 33645220583 scopus 로고    scopus 로고
    • Drug-induced liver injury: Summary of a single topic clinical research conference
    • Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006;43:618-631.
    • (2006) Hepatology. , vol.43 , pp. 618-631
    • Watkins, P.B.1    Seeff, L.B.2
  • 3
    • 32644469104 scopus 로고    scopus 로고
    • Drug-related hepatotoxicity
    • Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med. 2006;354:731-739.
    • (2006) N Engl J Med. , vol.354 , pp. 731-739
    • Navarro, V.J.1    Senior, J.R.2
  • 4
    • 34247259568 scopus 로고    scopus 로고
    • Drug-induced liver injury
    • Abboud G, Kaplowitz N. Drug-induced liver injury. Drug Saf. 2007;30:277-294.
    • (2007) Drug Saf. , vol.30 , pp. 277-294
    • Abboud, G.1    Kaplowitz, N.2
  • 5
    • 0037126649 scopus 로고    scopus 로고
    • Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States
    • Ostapowicz G, Fontana RJ, Schiødt FV, et al; U.S. Acute Liver Failure Study Group. 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.
    • (2002) Ann Intern Med. , vol.137 , pp. 947-954
    • Ostapowicz, G.1    Fontana, R.J.2    Schiødt, F.V.3
  • 6
    • 84900504101 scopus 로고    scopus 로고
    • Clinical Knowledge Summaries. Depression. National Institute for Helth and Care Excellence last revised 2010 Accessed December 20, 2013
    • Clinical Knowledge Summaries. Depression. National Institute for Helth and Care Excellence, last revised 2010. Available at: http://cks.nice.org.uk/ depression#!topicsummary. Accessed December 20, 2013.
  • 8
    • 0345376184 scopus 로고    scopus 로고
    • Nefazodone (Serzone) withdrawn because of hepatotoxicity
    • Choi S. Nefazodone (Serzone) withdrawn because of hepatotoxicity. CMAJ. 2003;169:1187.
    • (2003) CMAJ. , vol.169 , pp. 1187
    • Choi, S.1
  • 9
    • 0032917750 scopus 로고    scopus 로고
    • Welcome withdrawal of amineptine in France
    • Welcome withdrawal of amineptine in France. Prescrire Int. 1999;8:51.
    • (1999) Prescrire Int. , vol.8 , pp. 51
  • 10
    • 80051617616 scopus 로고    scopus 로고
    • A benefit-risk assessment of agomelatine in the treatment of major depression
    • Howland RH. A benefit-risk assessment of agomelatine in the treatment of major depression. Drug Saf. 2011;34:709-731.
    • (2011) Drug Saf. , vol.34 , pp. 709-731
    • Howland, R.H.1
  • 11
    • 84900521470 scopus 로고    scopus 로고
    • Direct Healthcare Professional Communication on the risk of hepatotoxicity with agomelatine (valdoxan/thymanax) Accessed July 1, 2013
    • Direct Healthcare Professional Communication on the risk of hepatotoxicity with agomelatine (valdoxan/thymanax). Available at: www.servier.com/sites/default/files/DHPC%20agomelatine.pdf. Accessed July 1, 2013.
  • 12
    • 0030665406 scopus 로고    scopus 로고
    • Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: A case/non-case study in the French pharmacovigilance system database
    • Moore N, Kreft-Jais C, Haramburu F, et al. Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: a case/non-case study in the French pharmacovigilance system database. Br J Clin Pharmacol. 1997;44:513-518.
    • (1997) Br J Clin Pharmacol. , vol.44 , pp. 513-518
    • Moore, N.1    Kreft-Jais, C.2    Haramburu, F.3
  • 13
    • 0032991290 scopus 로고    scopus 로고
    • The medical dictionary for regulatory activities (MedDRA)
    • Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20:109-117.
    • (1999) Drug Saf. , vol.20 , pp. 109-117
    • Brown, E.G.1    Wood, L.2    Wood, S.3
  • 14
    • 0034672296 scopus 로고    scopus 로고
    • Pharmacovigilance: A science or fielding emergencies?
    • Evans SJ. Pharmacovigilance: a science or fielding emergencies? Stat Med. 2000;19:3199-3209.
    • (2000) Stat Med. , vol.19 , pp. 3199-3209
    • Evans, S.J.1
  • 15
    • 4544368008 scopus 로고    scopus 로고
    • The reporting odds ratio and its advantages over the proportional reporting ratio
    • Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004;13:519-523.
    • (2004) Pharmacoepidemiol Drug Saf. , vol.13 , pp. 519-523
    • Rothman, K.J.1    Lanes, S.2    Sacks, S.T.3
  • 17
    • 80855144263 scopus 로고    scopus 로고
    • Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database
    • Montastruc JL, Sommet A, Bagheri H, et al. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011;72:905-908.
    • (2011) Br J Clin Pharmacol. , vol.72 , pp. 905-908
    • Montastruc, J.L.1    Sommet, A.2    Bagheri, H.3
  • 18
    • 4544327271 scopus 로고    scopus 로고
    • Disproportionality analyses of spontaneous reports
    • Hennessy S. Disproportionality analyses of spontaneous reports. Pharmacoepidemiol Drug Saf. 2004;13:503-504.
    • (2004) Pharmacoepidemiol Drug Saf. , vol.13 , pp. 503-504
    • Hennessy, S.1
  • 19
    • 0024336471 scopus 로고
    • Hepatic injury caused by mianserin
    • Otani K, Kaneko S, Tasaki H, et al. Hepatic injury caused by mianserin. BMJ. 1989;299:519.
    • (1989) BMJ. , vol.299 , pp. 519
    • Otani, K.1    Kaneko, S.2    Tasaki, H.3
  • 20
    • 0026439647 scopus 로고
    • Hepatotoxicity of mianserin: A case with positive reintroduction
    • Barbare JC, Biour M, Cadot T, et al. Hepatotoxicity of mianserin: a case with positive reintroduction. Gastroenterol Clin Biol. 1992;16:486-488.
    • (1992) Gastroenterol Clin Biol. , vol.16 , pp. 486-488
    • Barbare, J.C.1    Biour, M.2    Cadot, T.3
  • 22
    • 0020714636 scopus 로고
    • Toxicité hépatique des nouveaux anti-d épresseurs. A propos d'une observation
    • Zarski JP, Aubert H, Rachail M. Toxicité hépatique des nouveaux anti-d épresseurs. A propos d'une observation. Gastroenterol Clin Biol. 1983;7:220-221.
    • (1983) Gastroenterol Clin Biol. , vol.7 , pp. 220-221
    • Zarski, J.P.1    Aubert, H.2    Rachail, M.3
  • 23
    • 0019302361 scopus 로고
    • Mianserin: A possible cause of neutropenia and agranulocytosis
    • Adverse Drug Reactions Advisory Committee.
    • Adverse Drug Reactions Advisory Committee. Mianserin: a possible cause of neutropenia and agranulocytosis. Med J Aust. 1980;2:673-674.
    • (1980) Med J Aust. , vol.2 , pp. 673-674
  • 24
    • 0025352538 scopus 로고
    • Formation of cytotoxic metabolites from phenytoin, imipramine, desipramine, amitriptyline and mianserin by mouse and human hepatic microsomes
    • Riley RJ, Roberts P, Kitteringham NR, et al. Formation of cytotoxic metabolites from phenytoin, imipramine, desipramine, amitriptyline and mianserin by mouse and human hepatic microsomes. Biochem Pharmacol. 1990;39:1951-1958.
    • (1990) Biochem Pharmacol. , vol.39 , pp. 1951-1958
    • Riley, R.J.1    Roberts, P.2    Kitteringham, N.R.3
  • 25
    • 70350664784 scopus 로고    scopus 로고
    • European Medicines Agency Accessed July 1, 2013
    • European Medicines Agency. CMHP assessment report for valdoxan. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public- assessment-report/human/000915/WC500046226.pdf. Accessed July 1, 2013.
    • CMHP Assessment Report for Valdoxan
  • 26
    • 70350664784 scopus 로고    scopus 로고
    • European Medicines Agency Accessed July 1, 2013
    • European Medicines Agency. CMHP assessment report for valdoxan. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion- Initial-authorisation/human/000915/WC500059399.pdf. Accessed July 1, 2013.
    • CMHP Assessment Report for Valdoxan
  • 27
    • 84900467334 scopus 로고    scopus 로고
    • Agomelatine (valdoxan/thymanax): risk of dose-related hepatotoxicity and liver failureVupdated warnings and monitoring guidance. Drug Safety Update [serial online]. October 2012 Accessed July 1, 2013
    • Agomelatine (valdoxan/thymanax): risk of dose-related hepatotoxicity and liver failureVupdated warnings and monitoring guidance. Drug Safety Update [serial online]. October 2012, vol 6, issue 3: A1. Available at: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON199558. Accessed July 1, 2013.
    • , vol.6 , Issue.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.