Answers to the most common questions about the hepatic safety profile of duloxetine

Postgraduate Medicine

Volumn 120, Issue 2, 2008, Pages 111-118

  Wohlreich, Madelaine M ^a   Acharya, Nayan ^a   Strombom, Indiana ^a   Kuritzky, Louis ^b   Robinson, Michael ^a   Heinloth, Alexandra N ^c   Regev, Arie ^a   Wernicke, Joachim F ^a  

^a ELI LILLY AND COMPANY   (United States)

^b UNIVERSITY OF FLORIDA   (United States)

^c i3 Statprobe   (United States)

Author keywords

Antidepressants; Diabetic peripheral neuropathic pain; Duloxetine; Generalized anxiety disorder; Hepatotoxicity; Selective serotonin reuptake inhibitors

Indexed keywords

AMFEBUTAMONE; AMITRIPTYLINE; CITALOPRAM; DOXEPIN; DULOXETINE; FLUOXETINE; IMIPRAMINE; LIVER ENZYME; NEFAZODONE; PAROXETINE; SERTRALINE; VENLAFAXINE; ANTIDEPRESSANT AGENT; THIOPHENE DERIVATIVE;

CLINICAL TRIAL; DEPRESSION; DOCTOR PATIENT RELATION; DRUG APPROVAL; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG LABELING; DRUG MARKETING; DRUG PACKAGING; DRUG SAFETY; FIBROMYALGIA; FOOD AND DRUG ADMINISTRATION; GENERALIZED ANXIETY DISORDER; HEPATITIS; HUMAN; LIVER FAILURE; LIVER FUNCTION TEST; LIVER INJURY; LIVER NECROSIS; LIVER TOXICITY; LOWER URINARY TRACT SYMPTOM; MAJOR DEPRESSION; NEUROPATHIC PAIN; NOTE; POSTMARKETING SURVEILLANCE; RISK FACTOR; STRESS INCONTINENCE; CHEMICALLY INDUCED DISORDER; LIVER DISEASE; REVIEW; RISK ASSESSMENT; UNITED STATES;

ANTIDEPRESSIVE AGENTS; DEPRESSIVE DISORDER; DRUG APPROVAL; DRUG LABELING; HUMANS; LIVER DISEASES; RISK ASSESSMENT; THIOPHENES; UNITED STATES;

EID: 54049140072     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.3810/pgm.2008.07.1803     Document Type: Note

References (24)

1. DeSanty KP, Amabile CM. Antidepressant-induced liver injuiy. Ann Pharmacother. 2007;41(7):1201-1211.
2. Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med. 2006;354(7):731-739. (Pubitemid 43247143)
3. Bénichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol. 1990;11(2):272-276.
4. Lee WM, Senior JR. Recognizing drug-induced liver injury: current problems, possible solutions. Toxicol Pathol. 2005;33(1):155-164. (Pubitemid 40216814)
5. Food and Drug Administration. Hy's law and current practice: a hypothesis in use. http://www.fda.gov/cder/livertox/Presentations/ im1389/sld013.htm. Accessed July 17, 2007.
6. Watkins PB, Kaplowitz N, Slattery JT, et al, Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: a randomized controlled trial. JAMA. 2006;296(1):87-93.
7. Rosenzweig P, Miget N, Brohier S. Transaminase elevation on placebo during phase 1 trials: prevalence and significance. Br J Clin Pharmacol. 1999;48(1):19-23. (Pubitemid 29296658)
8. Clark JM, Brancati FL, Diehl AM. The prevalence and etiology of elevated aminotransferase levels in the United States. Am J Gastroenterol. 2003;98(5):960-967. (Pubitemid 36733754)
9. Wernicke J, Pangallo B, Wang F, Murray I, Henck J, Knadler MP, D'Souza DN, Uetrecht JP. Hepatic effects of duloxetine-I: non-clinical and clinical trial data. Current Drug Safety. 2008;3:132-142.
10. Wernicke J, Acharya N, Strombom I, Gahimer JL, D'Souza DN, Di Pietro N, Uetrecht JP. Hepatic effects of duloxetine - II: spontaneous reports and epidemiology of hepatic events. Current Drug Safety. 2008;3:143-153.
11. Liguori MJ, Waring JF. Investigations toward enhanced understanding of hepatic idiosyncratic drug reactions. Expert Opin Drug Metab Toxicol. 2006;2(6):835-846. (Pubitemid 44911535)
12. Hanje AJ, Pell LJ, Votolato NA, Frankel WL, Kirkpatrick RB. Case report: fulminant hepatic failure involving duloxetine hydrochloride. Clin Gastroenterol Hepatol. 2006;4(7):912-917. (Pubitemid 43994541)
13. Dull MS, Walker AM, Kronlund KH Jr. Descriptive epidemiology of acute liver enzyme abnormalities in the general population of central Massachusetts. Pharmacoepidemiol Drug Saf. 1999;8(4):275-283. (Pubitemid 29358553)
14. Sgro C, Clinard F, Ouazir K. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology. 2002;36(2):451-455. (Pubitemid 34810366)
15. 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(1):71-80. (Pubitemid 38901470)
16. Ibanez L, Perez E, Vidal X, Laporte JR; Grup d'Estudi Multicentric d'Hepatotoxicitat Aguda de Barcelona (GEMHAB). Prospective surveillance of acute serious liver disease unrelated to infectious, obstructive, or metabolic diseases: epidemiological and clinical features, and exposure to drugs. J Hepatol. 2002;37(5):592-600.
17. Strombom I, Wernicke J, Acharya N, D'Souza DN, Beyrer JK. Hepatic effects of duloxetine - III: Analysis of Hepatic Events Using External Data Sources. Current Drug Safety. 2008;3:154-162.
18. Cardona X, Avila A, Castellanos P. Venlafaxine-associated hepatitis. Ann Intern Med. 2000;132(5):417. (Pubitemid 30127784)
19. Horsmans Y, De CM, Sempoux C. Venlafaxine-associated hepatitis. Ann Intern Med. 1999;130(11):944.
20. Phillips BB, Digmann RR, Beck MG. Hepatitis associated with low- dose venlafaxine for postmenopausal vasomotor symptoms. Ann Pharmacother. 2006;40(2):323-327. (Pubitemid 43269866)
21. Sencan I, Sahin I, Ozcetin A. Low-dose venlafaxine-associated liver toxicity in chronic hepatitis. Ann Pharmacother. 2004;38(2):352-353. (Pubitemid 38112256)
22. Shaw MW, Sheard JD. Fatal venlafaxine overdose with acinar zone 3 liver cell necrosis. Am J Forensic Med Pathol. 2005;26(4):367-368. (Pubitemid 44357140)
23. Spigset O, Hägg S, Bate A. Hepatic injury and pancreatitis during treatment with serotonin reuptake inhibitors: data from the World Health Organization (WHO) database of adverse drug reactions. Int Clin Psychopharmacol. 2003;18(3):157-161. (Pubitemid 36571060)
24. Gahimer J, Wernicke J, Yalcin I, Ossana MJ, Wulster-Radcliffe M, Viktrup L. A retrospective pooled analysis of duloxetine safety in 23983 subjects. Cur Med Res Op, 2007;23(1):175-184. (Pubitemid 46191681)