Adverse events, toxicity and post-mortem data on duloxetine: Case reports and literature survey

Journal of Forensic and Legal Medicine

Volumn 17, Issue 4, 2010, Pages 175-185

  Vey, Eric L ^a   Kovelman, Inna ^b  

^a Erie County Coroner's Office   (United States)

^b Lehigh Valley Medical Center   (United States)

Author keywords

Autopsy; Duloxetine; Overdose; Post mortem; Suicide; Toxicity

Indexed keywords

ACETAMINOSALOL; AMFEBUTAMONE; BACLOFEN; BENZOYLECGONINE; CLONAZEPAM; CLOPIDOGREL; DIPHENHYDRAMINE; DULOXETINE; FENTANYL; FLUOXETINE; GABAPENTIN; HYDROCODONE; ISOSORBIDE; LEVOTHYROXINE; LISINOPRIL; LORAZEPAM; MECLOZINE; METOPROLOL; OXYCODONE; PANTOPRAZOLE; PARACETAMOL; QUETIAPINE; RISPERIDONE; SALSALATE; SERTRALINE; TEMAZEPAM; THEOPHYLLINE; TOLTERODINE; UNINDEXED DRUG; VENLAFAXINE; NARCOTIC ANALGESIC AGENT; SEROTONIN UPTAKE INHIBITOR; THIOPHENE DERIVATIVE;

ACCIDENTAL DEATH; ADULT; AGED; ANAMNESIS; ANXIETY DISORDER; ARTICLE; AUTOPSY; BACKACHE; CAUSE OF DEATH; CLINICAL ARTICLE; DEPRESSION; DIZZINESS; DRUG ABUSE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG FATALITY; DRUG INTOXICATION; FEMALE; HUMAN; HYPERTENSION; LEG PAIN; MALE; PARAMEDICAL DISCIPLINES; PRESCRIPTION; SLURRED SPEECH; SUICIDE; THROMBOSIS; ACCIDENT; BIOAVAILABILITY; CASE REPORT; CORONER; DRUG COMBINATION; FORENSIC TOXICOLOGY; MASS FRAGMENTOGRAPHY; MIDDLE AGED; REVIEW; TANDEM MASS SPECTROMETRY;

ACCIDENTS; ADULT; AGED; ANALGESICS, OPIOID; BIOLOGICAL AVAILABILITY; CORONERS AND MEDICAL EXAMINERS; DRUG THERAPY, COMBINATION; FEMALE; FENTANYL; FORENSIC TOXICOLOGY; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; HUMANS; MALE; MIDDLE AGED; SEROTONIN UPTAKE INHIBITORS; SUICIDE; TANDEM MASS SPECTROMETRY; THIOPHENES;

EID: 77954695257     PISSN: 1752928X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jflm.2010.02.002     Document Type: Review

References (52)

1. N. Sussman SNRIs versus SSRIs: mechanisms of action in treating depression and painful physical symptoms Primary Care Companion J Clin Psychiatry 5 S7 2003 19 26
2. D.K. Kajdasz, S. Iyengar, and D. Desaiah Duloxetine for the management of diabetic peripheral neuropathic pain: evidence-based findings from post hoc analysis of three multicenter, randomized, double-blind, placebo-controlled, parallel-group studies Clin Ther 29 Suppl. 2007 2536 2546
3. L.M. Arnold, A. Rosen, and Y.L. Pritchett A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder Pain 119 1-3 2005 5 15
4. < http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=305589 > [accessed 15.10.08].
5. W.A. Watson, T.L. Litovitz, and G.C. Rodgers Jr. 2004 Annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System Am J Emerg Med 23 5 2005 589 666
6. M.W. Lai, W. Klein-Schwartz, and G.C. Rodgers 2005 Annual report of the American Association of Poison Control Centers' national poisoning and exposure database Clin Toxicol (Phila) 44 6-7 2006 803 932
7. A.C. Bronstein, D.A. Spyker, L.R. Cantilena Jr., J. Green, B.H. Rumack, and S.E. Heard 2006 Annual report of the American Association of Poison Control Centers' National Poison Data System (NPDS) Clin Toxicol (Phila) 45 8 2007 815 917
8. Bronstein AC, Spyker DA, Cantilena Jr LR, Green JL, Rumack BH, Heard SE and American Association of Poison Control Centers. 2007 Annual report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 25th annual report. Clin Toxicol (Phila) 2008;46(10):927-1057.
9. D. Anderson, S. Reed, and J. Lintemoot A first look at duloxetine (Cymbalta) in a postmortem laboratory J Anal Toxicol 30 8 2006 576 580
10. Baselt RC. Disposition of toxic drugs and chemicals in man, 8th ed. Foster City, California: Biomedical Publications; 2008. p. 617, 1167.
11. Minyard AN, Nine JS, Smith RK. Identifying baclofen overdose at autopsy. Presented at the 51st annual meeting of the American Academy of Forensic Sciences. Orlando (FL); February 19, 1999.
12. M. Menchetti, B. Ferrari Gozzi, M. Addolorata Saracino, L. Mercolini, C. Petio, and M. Augusta Raggi Non-fatal overdose of duloxetine in combination with other antidepressants and benzodiazepines World J Biol Psychiatry 2008 1 5 [Epub ahead of print]
13. D.T. Wong, D.W. Robertson, F.P. Bymaster, J.H. Krushinski, and L.R. Reid LY227942, an inhibitor of serotonin and norepinephrine uptake: biochemical pharmacology of a potential antidepressant drug Life Sci 43 24 1988 2049 2057
14. S.H. Preskorn Duloxetine J Psychiatr Pract 10 6 2004 375 385
15. J. Yang, X. Lu, Y. Bi, F. Qin, and F. Li Chiral separation of duloxetine and its R-enantiomer by LC Chromatagraphia 66 5-6 2007 389 393
16. R.W. Fuller, S.K. Hemrick-Luecke, and H.D. Snoddy Effects of duloxetine, an antidepressant drug candidate, on concentrations of monoamines and their metabolites in rats and mice J Pharmacol Exp Ther 269 1 1994 132 136
17. Product information: Cipla therapeutic index - duloxyl (duloxetine hydrochloride). Mumbai, India: Cipla Ltd.; July, 2008. < http://www.cipladoc. com/therapeutic/admin.php?mode=prod&action=disp&id=446 >.
18. Prescribing information: Cymbalta (duloxetine hydrochloride) delayed-release capsules for oral use. Indianapolis (IN): Eli Lilly and Company; 2004, 2008 [revised 11.08.08].
19. A. Suri, S. Reddy, C. Gonzales, M.P. Knadler, R.A. Branch, and M.H. Skinner Duloxetine pharmacokinetics in cirrhotics compared with healthy subjects Int J Clin Pharmacol Ther 43 2 2005 78 84
20. M.H. Skinner, H.Y. Kuan, and A. Skerjanec Effect of age on the pharmacokinetics of duloxetine in women Br J Clin Pharmacol 57 1 2004 54 61
21. R.J. Lantz, T.A. Gillespie, and T.J. Rash Metabolism, excretion, and pharmacokinetics of duloxetine in healthy human subjects Drug Metab Dispos 31 2003 1142 1150
22. C. Chan, K.P. Yeo, A.X. Pan, M. Lim, M.P. Knadler, and D.S. Small Duloxetine pharmacokinetics are similar in Japanese and Caucasian subjects Br J Clin Pharmacol 63 3 2007 310 314
23. S.A. Chalon, L.A. Granier, and F.R. Vandenhende Duloxetine increases serotonin and norepinephrine availability in healthy subjects: a double-blind, controlled study Neuropsychopharmacology 28 9 2003 1685 1693
24. R.S. Lott, and D.E. Baker Duloxetine: a new antidepressant Adv Pharm 1 3 2003 228 241
25. M.P. Cruz, M.E. Gonzales, J. Jacobs, and M.C. LaFave Duloxetine HCL (Cymbalta) for the treatment of depression, neuorpathic pain, fibromyalgia, and stress urinary incontinence PT 31 2 2006 84 97
26. F.P. Bymaster, T.C. Lee, M.P. Knadler, M.J. Detke, and S. Iyengar The dual transporter inhibitor duloxetine: a review of its preclinical pharmacology, pharmacokinetic profile, and clinical results in depression Curr Pharm Des 11 12 2005 1475 1493
27. C.L. Ogden, C.D. Fryar, M.D. Carroll, and K.M. Flegal Mean body weight, height, and body mass index, United States 1960-2002 Adv Data 347 2004 1 17
28. A. Sharma, M.J. Goldberg, and B.J. Cerimele Pharmacokinetics and safety of duloxetine, a dual-serotonin and norepinephrine reuptake inhibitor J Clin Pharmacol 40 2 2000 161 167
29. N. Ma, B.K. Zhang, and H.D. Li Determination of duloxetine in human plasma via LC/MS and subsequent application to a pharmacokinetic study in healthy Chinese volunteers Clin Chim Acta 380 1-2 2007 100 105 (Pubitemid 46498036)
30. Kavanagh RE. New drug application: clinical pharmacology and biopharmaceutics review (#2), part 1- NDA21-427, Cymbalta® (Duloxetine HCl) EC capsules. Office of Clinical Pharmacology and Biopharmaceutics/Division of Pharmaceutical Evaluation I, Center for Drug Evaluation and Research, Food and Drug Administration: Approval Package for Application Number 21-427. Washington, DC; August 23, 2002. < http://www.fda.gov/cder/foi/nda/2004/021427-s000- Cymbalta.htm > [accessed 23.10.08].
31. M. Deuschle, E. Mase, and M. Zink Dyskinesia during treatment with duloxetine Pharmacopsychiatry 39 6 2006 237 238
32. T. Loper, and B. Touchet An acute attack of porphyria in a patient taking duloxetine Psychosomatics 48 2 2007 179 180
33. D.C. Ezzo, and P.N. Patel Facial flushing associated with duloxetine use Am J Health Syst Pharm 64 5 2007 495 496
34. P. Oulis, V.G. Masdrakis, N.A. Karakatsanis, E. Karapoulios, A.V. Kouzoupis, and C.R. Soldatos Duloxetine-induced cutaneous adverse reaction J Clin Psychopharmacol 28 1 2008 104 105
35. C. De Las Cuevas, and E.J. Sanz Duloxetine-induced excessive disturbing and disabling yawning J Clin Psychopharmacol 27 1 2007 106 107
36. Y. Balhara, R. Sagar, and S.T. Varghese Bleeding gums: duloxetine may be the cause J Postgrad Med 53 1 2007 44 45
37. V.J. Espeleta, W.H. Moore, P.B. Kane, and D. Baram Eosinophilic pneumonia due to duloxetine Chest 131 3 2007 901 903
38. B.R. Bergman, H.R. Reynolds, A.H. Skolnick, and D. Castillo A case of apical ballooning cardiomyopathy associated with duloxetine Ann Int Med 149 3 2008 218 219
39. CYMBALTA® (duloxetine hydrochloride) delayed-release capsules. Product labeling. Indianapolis (IN): Eli Lilly and Company; 2005.
40. A.J. Hanje, L.J. Pell, N.A. Votolato, W.L. Frankel, and R.B. Kirkpatrick Case report: fulminant hepatic failure involving duloxetine hydrochloride Clin Gastroenterol Hepatol 4 7 2006 912 917
41. C.A. Naranjo, U. Busto, and E.M. Sellers A method for estimating the probability of adverse drug reactions Clin Pharmacol Ther 30 2 1981 239 245 (Pubitemid 12149145)
42. G. Danan, and C. Benichou Causality assessment of adverse reactions to drugs. I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries J Clin Epidemiol 46 1993 1323 1330
43. V.A.J. Maria, and R.M.M. Victorino Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis Hepatology 26 1997 664 669
44. P. Eisenberg Safety data on Cymbalta® (duloxetine hydrochloride) - hepatic effects. Dear Health Care Professional letter 2005 Lilly Research Laboratories Indianapolis (IN)
45. < http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm151091.htm >. #Cymbalta [accessed 25.11.08].
46. < http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety- RelatedDrugLabelingChanges/ucm123474.htm > [accessed 25.11.08].
47. M. Schulz, and A. Schmoldt Therapeutic and toxic blood concentrations of more than 800 drugs and other xenobiotics Pharmazie 58 7 2003 447 474
48. A.L. Pélissier-Alicot, J.M. Gaulier, P. Champsaur, and P. Marquet Mechanisms underlying postmortem redistribution of drugs: a review J Anal Toxicol 27 8 2003 533 544
49. D.S. Cook, R.A. Braithwaite, and K.A. Hale Estimating antemortem drug concentrations from postmortem blood samples: the influence of postmortem redistribution J Clin Pathol 53 4 2000 282 285
50. R.C. Baselt Disposition of toxic chemicals in man 8th ed. 2008 Biomedical Publications Foster City, CA p. 134
51. C.F. Chong, and T.L. Wang An unusual presentation of baclofen overdose Emerg Med J 22 9 2005 673 674
52. G.C. Wall, A. Wasiak, and G.A. Hicklin An initially unsuspected case of baclofen overdose Am J Crit Care 15 6 2006 611 613