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Expert Opinion on Drug Safety Volume 4, 2005 - Issue 6
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Review

Safety and adverse event profile of duloxetine

Joachim F Wernicke Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. [email protected]
,
James Gahimer Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. [email protected]
,
Ilker Yalcin Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. [email protected]
,
Meghan Wulster-Radcliffe Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. [email protected]
&
Lars Viktrup Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. [email protected]
Pages 987-993 | Published online: 28 Oct 2005

Bibliography

  • BERK M, DU PLESSIS AD, BIRKETT M, RICHARDT D: An open-label study of duloxetine hydrochloride, a mixed serotonin and noradrenaline reuptake inhibitor, in patients with DSM-III-R major depressive disorder. Clin. Psychopharmacol (1997) 12:137–140.
  • GOLDSTEIN DJ, MALLINCKRODT C, LU Y et al.: Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. I. Clin. Psychiatry (2002) 63:225–231.
  • DETKE MJ, LU Y, GOLDSTEIN DJ et al.: Duloxetine, 60mg once daily, for major depressive disorder: a randomized double-blind placebo-controlled trial. Clin. Psychiatry (2002) 63:308–315.
  • DETKE MJ, LU Y, GOLDSTEIN DJ et al.: Duloxetine 60mg once daily dosing versus placebo in the acute treatment of major depression. I Psychiatr. Res. (2002) 36:383–390.
  • RASKIN J, GOLDSTEIN DJ, MALLINCKRODT C et al: Duloxetine in the long-term treatment of major depressive disorder. ./. Clin. Psychiatry (2003) 64:1237–1244.
  • NORTON PA, ZINNER NR, YALCIN I, BUMP RC: Duloxetine versus placebo in the treatment of stress urinary incontinence. Am.j Obstet. Cynecol. (2002) 187:40–48.
  • DMOCHOWSKI RR, MIKLOS JR, NORTON PA, ZINNER NR, YALCIN I, BUMP RC: Duloxetine versus placebo for the treatment of North American women with stress urinary incontinence. J. Uri)]. (2003) 170:1259–1263.
  • VAN KERREBROECK P, ABRAMS P, LANGE R et al.: Duloxetine versus placebo in the treatment of European and Canadian women with stress urinary incontinence. Br. J. Obstet. Cynaecol. (2004) 111:249–257.
  • MILLARD RJ, MOORE K, RENCKEN R, YALCIN I, BUMP RC: Duloxetine versus placebo in the treatment of stress urinary incontinence: a four-continent randomized clinical trial. BJUInt. (2004) 93:311–318.
  • HUDSON JI, WOHLREICH MM, KAJDASZ DK, MALLINCKRODT CH, WATKIN JG, MARTYNOV OV: Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo-controlled clinical trials. Hum. Psychopharmacol (2005) 20:327–341.
  • ••Addresses safety and efficacy In eight duloxetine MDD trials.
  • HURLEY D, TURNER CL, YALCIN I, VIKTRUP L, BAYGANI SK: Duloxetine for the treatment of stress urinary incontinence in women: an integrated analysis of safety. Eur. Obstet. Cynecol. Reprod. Biol. (2005) (In Press).
  • ••Addresses safety and efficacyIn four SUI trials.
  • GOLDSTEIN DJ, LU Y, DETKE MJ, LEE TC, IYENGAR S: Duloxetine versus placebo in patients with painful diabetic neuropathy. Path (2005) 116:109–118.
  • •Addresses safety and efficacy of duloxetine in a DPNP trial. Expert Op/n. Drug Sal (2005) 4(6)
  • MONTGOMERY SA, KASPER S: Depression: a long-term illness and its treatment. Int. Clin. Psychopharmacol (1998) 6:S23–S26.
  • REIMHERR FW, AMSTERDAM JD, QUITKIN FM et al.: Optimal length of continuation therapy in depression: a prospective assessment during long-term fluoxetine treatment. Am. J. Psychiatry (1998) 155:1247–1253.
  • HIRSCHFELD RM, MONTGOMERY SA, AGUGLIA E: Partial response and nonresponse to antidepressant therapy: current approaches and treatment options. I Clin. Psychiatry (2002) 63:826–837.
  • DETKE MJ, WILTSE CG, MALLINCKRODT CH et al: Duloxetine in the acute and long-term treatment of major depressive disorder: a placebo- and paroxetine-controlled trial. Eur. Neuropsychopharmacol (2004) 14:457–470.
  • PIAZZA LA, MARKOWITZ JC, KOCSIS JH et al.: Sexual functioning in chronically depressed patients treated with SSRI antidepressants: a pilot study. Am. J. Psychiatry (1997) 154:1757–1759.
  • DELGADO PL, BRANNAN SK, MALLINCKRODT CH et al: Sexual functioning in patients with major depressive disorder: duloxetine compared with paroxetine and placebo. Clin. Psychiatry (2005) 66:686–692.
  • PEET M: Induction of mania with selectiveserotonin re-uptake inhibitors and tricyclic antidepressants. BE J. Psychiatry (1994) 164:549–550.
  • DUNNER DL, D'SOUZA DN, KAJDASZ DK, DETKE MJ, RUSSELL JM: Is treatment-associated hypomania rare with duloxetine: Secondary analysis of controlled trials in non-bipolar depression. I Affect. Disord. (2005) 87:115–119.
  • VIKTRUP L, PERAHIA DG, TYLEE A: Duloxetine treatment of stress urinary incontinence in women does not induce mania or hypomania. Prim. Care Companion I. Clin. Psychiatry (2004) 6:239–243.
  • VIKTRUP L, YALCIN I: Duloxetine treatment of stress urinary incontinence in women: effects of demographics, obesity, chronic lung disease, hypoestrogenism, diabetes mellitus, and depression on efficacy. BE J. Gen. Pract. (2005) submitted.
  • CYMBALTA PACKAGE INSERT. Indianapolis, IN: Eli Lilly and Company (2005).
  • ABRAMS P, CARDOZO L, FALL M et al:The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the international continence society. Am. I Obstet. Gynecol (2002) 187:116–126.
  • VIKTRUP L, PANGALLO BA, DETKE MJ, ZINNER NR: Urinary side effects of duloxetine in the treatment of depression and stress urinary incontinence. Prim. Care Companion I. Clin. Psychiatry (2004) 6:65–73.
  • MURRAY JB: Cardiac disorders and antidepressant medications. J. Psycho]. (2000) 134:162–168.
  • SZABADI E, GASZNER P, BRADSHAW CM: The peripheral anticholinergic activity of tricyclic antidepressants: comparison of amitriptyline and desipramine in human volunteers. Br. Psychiatry (1980) 137:433–439.
  • GLASSMAN AH, PREUD'HOMME XA: Review of the cardiovascular effects of heterocyclic antidepressants. J. Psychiatry (1993) 54 (Suppl.) :16–22.
  • COMMITTEE ON SAFETY MEDICINES. QT interval prolongation with antipsychotics. Curr. Pro& Pharmacovig. (2001) 27:4.
  • GLASSMAN AH, BIGGER JT: Antipsychotic drugs: prolonged QTc interval, torsade de pointes, and sudden death. Am. J. Psychiatry (2001) 158:1774–1782.
  • SHARMA A, GOLDBERG MJ, CERIMELE BJ: Pharmacokinetics and safety of duloxetine, a dual-serotonin and norepinephrine reuptake inhibitor. Pharmacol (2000) 40:161–167.
  • ••Reviews the pharmacokineticsof duloxetine.
  • NEMEROFF CB, SCHATZBERG AF, GOLDSTEIN DJ et al.: Duloxetine for the treatment of major depressive disorder. Psychopharmacol Bull. (2002) 36(4):106–132.
  • DERBY M, ZHANG L, GONZALES C, CHAPPELL J, LUCAS R, CALLAGHAN JT: Poster presented at the American Society for Clinical Pharmacology and Therapeutics, March 2–5, Orlando, Florida, USA (2005).
  • ZHANG L, DERBY M, GONZALES C et al: Poster presented at the American Society for Clinical Pharmacology and Therapeutics, March 2–5, Orlando, Florida, USA (2005).
  • MOLLER HJ: Antidepressants - do they decrease or increase suicidality? Pharmacopsychiatry (1992) 25:249–253.
  • SKINNER MH, KUAN HY, PAN A et al: Duloxetine is both an inhibitor and a substrate of cytochrome P4502D6 in healthy volunteers. Clin. Pharmacol Ther. (2003) 73:170–177.
  • LANTZ RJ, GILLESPIE TA, RASH TJ et al: Metabolism, excretion, and pharmacokinetics of duloxetine in healthy human subjects. Drug Metab. Dispos. (2003) 31:1142–1150.
  • •Reviews human metabolism of duloxetine.
  • WOHLREICH MM, MALLINCKRODT CH, WATKIN JG, HAY DP: Duloxetine for the long-term treatment of major depressive disorder in patients aged 65 and older: an open-label study. BMC Geriatr. (2004) 4:11.

Websites

  • http://www.fda.gov/OHRIVIS/DOCKETS/ 98fr/061402f.pdf FDA website Draft consensus guidelines

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