Hepatotoxicity associated with agomelatine and other antidepressants: Disproportionality analysis using pooled pharmacovigilance data from the Uppsala Monitoring Centre

Journal of Clinical Pharmacology

Volumn 55, Issue 7, 2015, Pages 768-773

  Gahr, Maximilian ^a   Zeiss, René ^a   Lang, Dirk ^a   Connemann, Bernhard J ^a   Schönfeldt Lecuona, Carlos ^a  

^a UNIVERSITY OF ULM   (Germany)

Author keywords

adverse drug reaction; drug safety; liver enzymes; signal detection

Indexed keywords

AGOMELATINE; AMFEBUTAMONE; AMINEPTINE; AMITRIPTYLINE; CLOMIPRAMINE; DULOXETINE; ESCITALOPRAM; FLUOXETINE; FLUVOXAMINE; MAPROTILINE; MIANSERIN; MILNACIPRAN; MIRTAZAPINE; MOCLOBEMIDE; NEFAZODONE; NORTRIPTYLINE; PAROXETINE; REBOXETINE; SERTRALINE; TIANEPTINE; TRANYLCYPROMINE; TRAZODONE; TRIMIPRAMINE; VENLAFAXINE; ACETAMIDE DERIVATIVE; ANTIDEPRESSANT AGENT;

ADVERSE OUTCOME; ARTICLE; CLINICAL ASSESSMENT; CLINICAL EVALUATION; COMPARATIVE STUDY; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG INDUSTRY; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN MEDICINES AGENCY; HUMAN; HYPERICUM PERFORATUM; LIVER TOXICITY; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; RISK FACTOR; SIGNAL DETECTION; WORLD HEALTH ORGANIZATION; DRUG-INDUCED LIVER INJURY; SWEDEN;

ACETAMIDES; ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTIDEPRESSIVE AGENTS; DRUG-INDUCED LIVER INJURY; HUMANS; PHARMACOVIGILANCE; SWEDEN;

EID: 84930623541     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.475     Document Type: Article

References (31)

1. Schuster D, Laggner C, Langer T,. Why drugs fail: a study on side effects in new chemical entities. Cur Pharm Des. 2005; 11: 3545-3559.
2. Temple R, Himmel M,. Safety of newly approved drugs: implications for prescribing. JAMA. 2002; 287: 2273-2275.
3. Selim K, Kaplowitz N,. Hepatotoxicity of psychotropic drugs. Hepatology. 1999; 29: 1347-1351.
4. DeSanty K, Amabile C,. Antidepressant-induced liver injury. Ann Pharmacother. 2007; 41: 1201-1211.
5. Lasser K, Allen P, Woolhandler S, et al., Timing of new black box warnings,withdrawals for prescription medications. JAMA. 2002; 287 (17): 2215-2220.
6. Voican C, Corruble E, Naveau S, Perlemuter G,. Antidepressant-induced liver injury: a review for clinicians. Am J Psychiatry. 2014; 171: 404-415.
7. Choi S,. Nefazodone (Serzone) withdrawn because of hepatotoxicity. CMAJ. 2003; 169 (11): 1187.
8. Welcome withdrawal of amineptine in France. Prescrire Int. 1999;8(40):51.
9. EMEA. CHMP 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 May 5, 2014.
10. Montastruc F, Scotto S, Vaz I, et al., Hepatotoxicity related to agomelatine and other new antidepressants: a case/noncase approach with information from the Portuguese, French, Spanish, and Italian pharmacovigilance systems. J Clin Psychopharmacol. 2014; 34 (3): 327-330.
11. Gahr M, Freudenmann R, Connemann B, Hiemke C, Schönfeldt-Lecuona C,. Agomelatine and hepatotoxicity: implications of cumulated data derived from spontaneous reports of adverse drug reactions. Pharmacopsychiatry. 2013; 56 (6): 214-220.
12. Howland R,. A benefit-risk assessment of agomelatine in the treatment of major depression. Drug Saf. 2011; 34: 709-731.
13. EMA. Valdoxan/Thymanax (agomelatine). Assessment report for a variation including a contraindication. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR--Assessment-Report--Variation/human/000915/WC500157713.pdf. Accessed May 12, 2014.
14. EMA. Valdoxan (Agomelatine). Summary of product characteristics (last updated: 10/12/2013). Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000915/WC500046227.pdf. Accessed May 11, 2014.
15. Brown E, Wood L, Wood S,. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999; 20 (2): 109.
16. van Manen R, Fram D, DuMouchel W,. Signal detection methodologies to support effective safety management. Expert Opin Drug Saf. 2007; 6 (4): 451-464.
17. Gould A,. Practical pharmacovigilance analysis strategies. Pharmacoepidemiol Drug Saf. 2003; 12 (7): 559-574.
18. Ooba N, Kubota K,. Selected control events and reporting odds ratio in signal detection methodology. Pharmacoepidemiol Drug Saf. 2010; 19 (11): 1159-1165.
19. Bate A, Evans S,. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009; 18 (6): 427-436.
20. Finney D,. Statistical logic in the monitoring of reactions to therapeutic drugs. Methods Inf Med. 1971; 10: 237-245.
21. van Puijenbroek E, Bate A, Leufkens H, et al., A comparison of measures of disproporttionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002; 11 (1): 3-10.
22. Rothman K, Lanes S, Sacks S,. The reporting odds ratio and its advantages over the proportional reporting odds ratio. Drug Saf. 2004; 13 (8): 519-523.
23. Evans S,. Pharmacovigilance: a science or fielding emergencies? Stat Med. 2000; 19 (23): 3199-3209.
24. Dostert P, Benedetti M, Poggesi I,. Review of the pharmacokinetics and metabolism of reboxetine, a selective noradrenaline reuptake inhibitor. Eur Neuropsychopharmacol. 1997; 7 (Suppl 1): S23-S35; discussion S71-S73.
25. Pariente A, Gregoire F, Fourrier-Reglat A, Haramburu F, Moore N,. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias. Drug Saf. 2007; 30 (10): 891-898.
26. Montastruc J, Sommet A, Bagheri H, Lapeyre-Mestre M,. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011; 72 (6): 905-908.
27. Bate A, Evans S,. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009; 18 (6): 427-436.
28. Harpaz R, DuMouchel W, Shah N, et al., Novel data-mining methodologies for adverse drug event discovery and analysis. Clin Pharmacol Ther. 2012; 91 (6): 1010-1021.
29. Otani K, Kaneko S, Tasaki H, Fukushima Y,. Hepatic injury caused by mianserin. BMJ. 1989; 299 (6697): 519.
30. Barbare JMB, Cadot T, Latrive J,. Hepatotoxicity of mianserin: a case with positive reintroduction. Gastroenterol Clin Biol. 1992; 16 (5): 486-488.
31. DeSanty K, Amabile C,. Antidepressant-induced liver injury. Ann Pharmacother. 2007; 41 (7): 1201-1211.