Drug safety evaluation of ziprasidone

Expert Opinion on Drug Safety

Volumn 10, Issue 3, 2011, Pages 437-448

  Citrome, Leslie ^a  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

antipsychotic; bipolar disorder; dosing; QT interval; safety; schizophrenia; tolerability; ziprasidone

Indexed keywords

ANTACID AGENT; ANTIHYPERTENSIVE AGENT; BENZATROPINE; CHOLESTEROL; CIMETIDINE; CLOZAPINE; DEXTROMETHORPHAN; DOPAMINE 2 RECEPTOR; FLUOXETINE; HALOPERIDOL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; KETOCONAZOLE; LITHIUM; LORAZEPAM; LOW DENSITY LIPOPROTEIN; METFORMIN; OLANZAPINE; ORAL CONTRACEPTIVE AGENT; PLACEBO; PROLACTIN; QUETIAPINE; SEROTONIN 2A RECEPTOR; TRAZODONE; TRIACYLGLYCEROL; VALPROIC ACID; ZIPRASIDONE;

ABNORMAL LABORATORY RESULT; ABNORMAL VISION; AGRANULOCYTOSIS; AKATHISIA; ANXIETY; ARTICLE; ASTHENIA; BINDING AFFINITY; BIPOLAR I DISORDER; BIPOLAR MANIA; BODY TEMPERATURE DISORDER; CLINICAL TRIAL (TOPIC); COGNITIVE DEFECT; DIABETES MELLITUS; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG ERUPTION; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; DYSPHAGIA; DYSTONIA; ELECTROLYTE DISTURBANCE; EXTRAPYRAMIDAL SYMPTOM; HUMAN; HYPERGLYCEMIA; HYPERPROLACTINEMIA; LACTATION; LEUKOPENIA; MAINTENANCE THERAPY; MONOTHERAPY; MORTALITY; MOTOR DYSFUNCTION; NAUSEA; NEUROLEPTIC MALIGNANT SYNDROME; NEUTROPENIA; ORTHOSTATIC HYPOTENSION; PREGNANCY; PRIAPISM; QT PROLONGATION; RECOMMENDED DRUG DOSE; RESPIRATORY TRACT INFECTION; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SEIZURE THRESHOLD; SIDE EFFECT; SOMNOLENCE; SUICIDE; SYNCOPE; TARDIVE DYSKINESIA; URTICARIA; VOMITING; WEIGHT GAIN;

ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; CLINICAL TRIALS AS TOPIC; DRUG TOXICITY; HUMANS; LONG QT SYNDROME; PIPERAZINES; SCHIZOPHRENIA; THIAZOLES;

EID: 79955444922     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.2011.560114     Document Type: Article

References (53)

1. Davis R, Markham A. Ziprasidone. CNS Drugs 1997;8(2):153-9 (Pubitemid 27364197)
2. Remington G. Atypical antipsychotics: where does ziprasidone fit? Expert Rev Neurother 2002;10(1):13-24 (Pubitemid 34625466)
3. Greenberg WM, Citrome L. Ziprasidone for schizophrenia and bipolar disorder - a review of the clinical trials. CNS Drug Rev 2007;13(2):137-77 (Pubitemid 47052346)
4. Citrome L. Ziprasidone HCl capsules for the adjunctive maintenance treatment of bipolar disorder in adults. Expert Rev Neurother 2010;10(7):1031-7
5. Citrome L. Using ziprasidone effectively: the food effect and dose response. Adv Ther 2009;26(8):739-48
6. Pfizer. Geodon: US Package Insert for Geodon (ziprasidone HCl) and Geodon (ziprasidone mesylate) for injection. LAB-0273-17.0; revised December 2010. Available from: http://www.pfizer. com/files/products/uspi-geodon.pdf. [Last accessed 21 December 2010]
7. Stahl SM. Stahls Essential Psychopharmacology. 3rd edition. Cambridge University Press, Cambridge; 2008
8. Shayegan DK, Stahl SM. Atypical antipsychotics: matching receptor profile to individual patients clinical profile. CNS Spectr 2004;9(Suppl 11):6-14 (Pubitemid 39473434)
9. Citrome L, Yang R, Glue P, et al. Effect of ziprasidone dose on all-cause discontinuation rates in acute schizophrenia and schizoaffective disorder: a post-hoc analysis of 4 fixed-dose randomized clinical trials. Schizophr Res 2009;111(1-3):39-45
10. Lesem MD, Zajecka JM, Swift RH, et al. Intramuscular ziprasidone, 2 mg versus 10 mg, in the short-term management of agitated psychotic patients. J Clin Psychiatry 2001;62(1):12-18 (Pubitemid 32154312)
11. Daniel DG, Potkin SG, Reeves KR, et al. Intramuscular (IM) ziprasidone 20 mg is effective in reducing acute agitation associated with psychosis: a double-blind, randomized trial. Psychopharmacology 2001;155(2):128-34 (Pubitemid 32417820)
12. Keck PE Jr, Versiani M, Potkin S, et al. For the Ziprasidone in Mania study group. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry 2003;160(4):741-8 (Pubitemid 41079608)
13. Potkin S, Keck P, Segal S, et al. Ziprasidone in Acute Bipolar Mania: A 21-day randomized, double-blind, placebo-controlled replication trial. J Clin Psychopharmacol 2005;25(4):301-10 (Pubitemid 41065070)
14. Bowden CL, Vieta E, Ice KS, et al. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry 2010;71(2):130-7
15. Pfizer Healthcare Ireland. Geodon Capsules 20mg, 40mg, 60mg, 80mg Summary of Product Characteristics; revised 06 November 2009. Available from: http://www.medicines.ie/ medicine/6166/SPC/GEODON+Capsules+20mg,+40mg,+60mg, +80mg/. [Last accessed 22 December 2010]
16. Citrome L. Comparison of intramuscular ziprasidone, olanzapine, or aripiprazole for agitation: a quantitative review of efficacy and safety. J Clin Psychiatry 2007;68(12):1876-85
17. Andersohn F, Schmedt N, Weinmann S, et al. Priapism associated with antipsychotics: role of alpha1 adrenoceptor affinity. J Clin Psychopharmacol 2010;30(1):68-71
18. Kaufman KR, Stern L, Mohebati A, et al. Ziprasidone-induced priapism requiring surgical treatment. Eur Psychiatry 2006;21(1):48-50 (Pubitemid 43243052)
19. Citrome L. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf 2009;4(3):229-37
20. Glassman AH, Bigger JT Jr. Antipsychotic drugs: prolonged QTc interval, torsade de pointes, and sudden death. Am J Psychiatry 2001;158(11):1774-82 (Pubitemid 33054769)
21. Pfizer. FDA Psychopharmacological Drugs Advisory Committee. Briefing document for Zeldox- capsules (Ziprasidone HCl). New York: Pfizer, Inc., July 19, 2000. Available from: http://www.fda.gov/ohrms/dockets/ac/00/ backgrd/3619b1a.pdf. [Last accessed 22 December 2010].
22. Heinrich TW, Biblo LA, Schneider J. Torsades de pointes associated with ziprasidone. Psychosomatics 2006;47(3):264-8 (Pubitemid 46940487)
23. Alipour A, Cruz R, Lott RS. Torsade de pointes after ziprasidone overdose with coingestants. J Clin Psychopharmacol 2010;30(1):76-7
24. Manini AF, Raspberry D, Hoffman RS, et al. QT prolongation and Torsades de Pointes following overdose of ziprasidone and amantadine. J Med Toxicol 2007;3(4):178-81
25. Miceli JJ, Tensfeldt TG, Shiovitz T, et al. Effects of oral ziprasidone and oral haloperidol on QTc interval in patients with schizophrenia or schizoaffective disorder. Pharmacotherapy 2010;30(2):127-35
26. Levy WO, Robichaux-Keene NR, Nunez C. No significant QTc interval changes with high-dose ziprasidone: a case series. J Psychiatr Pract 2004;10(4):227-32 (Pubitemid 38988937)
27. Miceli JJ, Tensfeldt TG, Shiovitz T, et al. Effects of high dose ziprasidone and haloperidol on the QTc interval after intramuscular administration: a randomized, single-blind, parallel-group study in patients with schizophrenia or schizoaffective disorder. Clin Therapeutics 2010;32(3):472-91
28. Taylor D. Ziprasidone in the management of schizophrenia: the QT interval issue in context. CNS Drugs 2003;17(6):423-30 (Pubitemid 36560704)
29. Arato M, OConnor R, Meltzer HY. ZEUS study group. A 1-year, double-blind, placebo-controlled trial of ziprasidone 40, 80 and 160 mg/day in chronic schizophrenia: the Ziprasidone Extended Use in Schizophrenia (ZEUS) study. Int Clin Psychopharmacol 2002;17(5):207-15
30. Allison DB, Mentore JL, Heo M, et al. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry 1999;156(11):1686-96 (Pubitemid 29517559)
31. Addington DE, Pantelis C, Dineen M, et al. Efficacy and tolerability of ziprasidone versus risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder: an 8-week, double-blind, multicenter trial. J Clin Psychiatry 2004;65(12):1624-33
32. Hirsch SR, Kissling W, Bauml J, et al. A 28-week comparison of ziprasidone and haloperidol in outpatients with stable schizophrenia. J Clin Psychiatry 2002;63(6):516-23 (Pubitemid 34680361)
33. Kinon BJ, Lipkovich I, Edwards SB, et al. A 24-week randomized study of olanzapine versus ziprasidone in the treatment of schizophrenia or schizoaffective disorder in patients with prominent depressive symptoms. J Clin Psychopharmacol 2006;26(2):157-62 (Pubitemid 43740339)
34. Simpson GM, Weiden P, Pigott T, et al. Six-month, blinded, multicenter continuation study of ziprasidone versus olanzapine in schizophrenia. Am J Psychiatry 2005;162(8):1535-8 (Pubitemid 41105572)
35. Breier A, Berg PH, Thakore JH, et al. Olanzapine versus ziprasidone: results of a 28-week double-blind study in patients with schizophrenia. Am J Psychiatry 2005;162(10):1879-87 (Pubitemid 41428617)
36. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;353(12):1209-23 (Pubitemid 41345943)
37. Stroup TS, Lieberman JA, McEvoy JP, et al. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry 2006;163(4):611-22 (Pubitemid 44464570)
38. Kahn RS, Fleischhacker WW, Boter H, et al. Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet 2008;371(9618):1085-97 (Pubitemid 351418005)
39. Sanchez-Barranco P. New onset of diabetes mellitus with ziprasidone: a case report. J Clin Psychiatry 2005;66(2):268-9 (Pubitemid 40314339)
40. American diabetes association, American psychiatric association, American association of clinical endocrinologists, North American association for the study of obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care 2004;27(2):596-601
41. Strom BL, Eng SM, Faich G, et al. Comparative mortality associated with ziprasidone and olanzapine in real-world use among 18,154 patients with schizophrenia: the Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC). Am J Psychiatry 2010. [Epub ahead of print]
42. Citrome L, Jaffe A, Levine J. How dosing of ziprasidone in a state hospital system differs from product labeling. J Clin Psychiatry 2009;70(7):975-82
43. Deutschman DA, Deutschman DH. High-dose ziprasidone in treatment-resistant schizophrenia and affective spectrum disorders. J Clin Psychopharmacol 2007;27(5):513-14 (Pubitemid 47415053)
44. Mech AW. High-dose ziprasidone monotherapy in bipolar I disorder patients with depressed or mixed episodes. J Clin Psychopharmacol 2008;28(2):240-1 (Pubitemid 351417133)
45. Rosenfield PJ, Girgis RR, Gil R. High-dose ziprasidone-induced acute dystonia. Prog Neuropsychopharmacol Biol Psychiatry 2007;31(2):546-7 (Pubitemid 46209424)
46. Citrome L. A review of aripiprazole in the treatment of patients with schizophrenia or bipolar I disorder. Neuropsychiatr Dis Treat 2006;2(4):427-43 (Pubitemid 46321873)
47. Citrome L. Iloperidone for schizophrenia: a review of the efficacy and safety profile for this newly commercialised second-generation antipsychotic. Int J Clin Pract 2009;63(8):1237-48
48. Citrome L. Asenapine for schizophrenia and bipolar disorder: a review of the efficacy and safety profile for this newly approved sublingually absorbed second-generation antipsychotic. Int J Clin Pract 2009;63(12):1762-84
49. Citrome L. Lurasidone for schizophrenia: a review of the efficacy and safety profile for this newly approved second-generation antipsychotic. Int J Clin Pract 2011;65(2):189-210
50. Hondeghem LM. Thorough QT/QTc not so thorough: removes torsadogenic predictors from the T-wave, incriminates safe drugs, and misses profibrillatory drugs. J Cardiovasc Electrophysiol 2006;17(3):337-40 (Pubitemid 43344952)
51. Goff D. High-dose ziprasidone versus conventional dosing in schizophrenia patients with residual symptoms (HDZ). NCT00403546. Available from: http://www.clinicaltrials. gov/ct2/show/NCT00403546. [Last accessed 25 January 2011]
52. Volavka J, Citrome L. Oral antipsychotics for the treatment of schizophrenia: heterogeneity in efficacy and tolerability should drive decision-making. Expert Opin Pharmacother 2009;10(12):1917-28
53. Leucht S, Corves C, Arbter D, et al. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 2009;373(9657):31-41