Quetiapine and the need for a thorough QT/QTc study

Journal of Clinical Psychopharmacology

Volumn 34, Issue 1, 2014, Pages 3-6

  Hasnain, Mehrul ^a   Vieweg, W Victor R ^b   Howland, Robert H ^c   Kogut, Christopher ^b   Breden Crouse, Ericka L ^d   Koneru, Jayanthi N ^b,d   Hancox, Jules C ^e   Digby, Geneviève C ^f   Baranchuk, Adrian ^f   Deshmukh, Anand ^g   Pandurangi, Ananda K ^b  

^a MEMORIAL UNIVERSITY OF NEWFOUNDLAND   (Canada)

^b VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PITTSBURGH   (United States)

^d VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^e UNIVERSITY OF BRISTOL   (United Kingdom)

^f QUEEN S UNIVERSITY   (Canada)

^g CREIGHTON UNIVERSITY CARDIAC CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLMETHADOL; ANTIARRHYTHMIC AGENT; ANTIDEPRESSANT AGENT; CISAPRIDE; DOFETILIDE; DOPAMINE; GATIFLOXACIN; GREPAFLOXACIN; HALOPERIDOL; MOXIFLOXACIN; NEUROLEPTIC AGENT; OLANZAPINE; PHENOTHIAZINE DERIVATIVE; POTASSIUM CHANNEL HERG; QUETIAPINE; QUINIDINE; SERTINDOLE; TERFENADINE; THIORIDAZINE;

CARDIOVASCULAR RISK; CLINICAL ASSESSMENT; DRUG BLOOD LEVEL; DRUG INDUSTRY; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; GENE; HEART PROARRHYTHMIA; HUMAN; IC 50; INTENSIVE CARE UNIT; MEDICAL INFORMATION; NONHUMAN; PRIORITY JOURNAL; QT PROLONGATION; REVIEW; RISK FACTOR; TORSADE DES POINTES;

ANIMALS; ANTIPSYCHOTIC AGENTS; DIBENZOTHIAZEPINES; ETHER-A-GO-GO POTASSIUM CHANNELS; EVIDENCE-BASED MEDICINE; HEART CONDUCTION SYSTEM; HUMANS; LONG QT SYNDROME; POTASSIUM CHANNEL BLOCKERS; RISK ASSESSMENT; RISK FACTORS; TORSADES DE POINTES;

EID: 84891739919     PISSN: 02710749     EISSN: 1533712X     Source Type: Journal    
DOI: 10.1097/JCP.0000000000000075     Document Type: Review

References (37)

1. AstraZeneca. Quetiapine (Seroquel) Prescribing Information. Available at: http://www1.astrazeneca-us.com/pi/Seroquel.pdf. Accessed November 13, 2013.
2. Darpo B. The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance. Br J Pharmacol. 2010;159:49-57.
3. Stockbridge N, Zhang J, Garnett C, et al. Practice and challenges of thorough QT studies. J Electrocardiol. 2012;45:582-587.
4. Anonymous. Quetiapine (Seroquel) and QT-interval prolongation. Med Lett Drugs Ther. 2011;53:79.
5. Hales RE, Yudofsky SC, Gabbard GO. The American Psychiatric Publishing Textbook of Psychiatry. Arlington, VA: American Psychiatric Publishing; 2008.
6. Zeneca Pharmaceuticals. NDA 20-639 (Quetiapine Fumarate). Available at: http://www.accessdata.fda.gov/drugsatfda-docs/nda/97/020639ap-Seroquel-medrP2. pdf. Accessed November 13, 2013.
7. Dessertenne F. Tachycardie ventriculaire a deux foyers opposes variables. Arch Mal Coeur Vaiss. 1966;59:263-272.
8. Selzer A, Wray HW. Quinidine syncope. Paroxysmal ventricular fibrillation occurring during treatment of chronic atrial arrhythmias. Circulation. 1964;30:17-26.
9. Kelly HG, Fay JE, Laverty SG. Thioridazine hydrochloride (Mellaril): its effect on the electrocardiogram and a report of two fatalities with electrocardiographic abnormalities. Can Med Assoc J. 1963;89:546-554.
10. Desautels S, Filteau C, St-Jean A. Ventricular tachycardia associated with administration of thioridazine hydrochloride (Mellaril): report of a case with a favourable outcome. Can Med Assoc J. 1964;90:1030-1031.
11. Ban TA, St Jean A. The effect of phenothiazines on the electrocardiogram. Can Med Assoc J. 1964;91:537-540.
12. Fowler NO, McCall D, Chou TC, et al. Electrocardiographic changes and cardiac arrhythmias in patients receiving psychotropic drugs. Am J Cardiol. 1976;37:223-230.
13. Stockbridge N, Morganroth J, Shah RR, et al. Dealing with global safety issues: was the response to QT-liability of non-cardiac drugs well coordinated? Drug Saf. 2013;36:167-182.
14. Botstein P. Is QT interval prolongation harmful? A regulatory perspective. Am J Cardiol. 1993;72:50B-52B.
15. Lipicky RJ. A viewpoint on drugs that prolong the QTc interval. Am J Cardiol. 1993;72:53B-54B.
16. Roden DM. Current status of class III antiarrhythmic drug therapy. Am J Cardiol. 1993;72:44B-49B.
17. Clarke A, Deeks JJ, Shakir SA. An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets. Drug Saf. 2006;29:175-181.
18. Olivier P, Montastruc JL. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiol Drug Saf. 2006;15:808-812.
19. Shah RR. Drugs, QTc interval prolongation and final ICH E14 guideline: an important milestone with challenges ahead. Drug Saf. 2005;28:1009-1028.
20. Shah RR, Morganroth J. Early investigation of QTc liability: the role of multiple ascending dose (MAD) study. Drug Saf. 2012;35:695-709.
21. Jenzer HR, Hagemeijer F. Quinidine syncope: torsade de pointes with low quinidine plasma concentrations. Eur J Cardiol. 1976;4:447-451.
22. Kay GN, Plumb VJ, Arciniegas JG, et al. Torsade de pointes: the long-short initiating sequence and other clinical features: observations in 32 patients. J Am Coll Cardiol. 1983;2:806-817.
23. Anonymous. Withdrawal of troglitazone and cisapride. JAMA. 2000;283(17):2228.
24. Food and Drug Administration. E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129335.htm. Accessed November 13, 2013.
25. Vieweg WV, Wood MA, Fernandez A, et al. Proarrhythmic risk with antipsychotic and antidepressant drugs: implications in the elderly. Drugs Aging. 2009;26:997-1012.
26. Witchel HJ, Hancox JC. Familial and acquired long QT syndrome and the cardiac rapid delayed rectifier potassium current. Clin Exp Pharmacol Physiol. 2000;27:753-766.
27. Gintant GA. Preclinical torsades-de-pointes screens: advantages and limitations of surrogate and direct approaches in evaluating proarrhythmic risk. Pharmacol Ther. 2008;119:199-209.
28. Hancox JC, McPate MJ, El Harchi A, et al. The hERG potassium channel and hERG screening for drug-induced torsades de pointes. Pharmacol Ther. 2008;119:118-132.
29. Rampe D, Murawsky MK, Grau J, et al. The antipsychotic agent sertindole is a high affinity antagonist of the human cardiac potassium channel HERG. J Pharmacol Exp Ther. 1998;286:788-793.
30. Katchman AN, Koerner J, Tosaka T, et al. Comparative evaluation of HERG currents and QT intervals following challenge with suspected torsadogenic and nontorsadogenic drugs. J Pharmacol Exp Ther. 2006;316:1098-1106.
31. Milnes JT, Witchel HJ, Leaney JL, et al. hERG K+ channel blockade by the antipsychotic drug thioridazine: An obligatory role for the S6 helix residue F656. Biochem Biophys Res Commun. 2006;351:273-280.
32. Kim KS, Kim EJ. The phenothiazine drugs inhibit hERG potassium channels. Drug Chem Toxicol. 2005;28:303-313.
33. Redfern WS, Carlsson L, Davis AS, et al. Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development. Cardiovasc Res. 2003;58:32-45.
34. Kongsamut S, Kang J, Chen XL, et al. A comparison of the receptor binding and HERG channel affinities for a series of antipsychotic drugs. Eur J Pharmacol. 2002;450:37-41.
35. AstraZeneca. Advisory Committee Briefing Document: Drug Substance: Quetiapine Fumarate Extended Release. Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ PsychopharmacologicDrugsAdvisoryCommittee/UCM161963.pdf. Accessed November 13, 2013.
36. Hasnain M, Vieweg WV, Howland RH, et al. Quetiapine, QTc interval prolongation, and torsade de pointes: a review of case reports. Ther Adv Psychopharmacol. 2013. doi: 10.1177/2045125313510194.
37. Vieweg WV, Hasnain M, Wood MA, et al. Cardiometabolic risks of antidepressant and antipsychotic drugs, part 1. Proarrhythmic risks of antidepressant and antipsychotic drugs. Psychiatric Times. 2011;28:50-55.