PRO: The food and drug administration black box warning on droperidol is not justified

Anesthesia and Analgesia

Volumn 106, Issue 5, 2008, Pages 1414-1417

  Habib, Ashraf S ^a,b   Gan, Tong J ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DUKE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATROPINE; DESFLURANE; DOLASETRON MESILATE; DROPERIDOL; GLYCOPYRRONIUM BROMIDE; GRANISETRON; ISOFLURANE; NEOSTIGMINE; ONDANSETRON; SEVOFLURANE; SUXAMETHONIUM; THIOPENTAL; ANTIEMETIC AGENT;

DRUG SAFETY; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HEART ARRHYTHMIA; HEART VENTRICLE TACHYCARDIA; HUMAN; POSTOPERATIVE NAUSEA AND VOMITING; PRIORITY JOURNAL; PROPHYLAXIS; QT PROLONGATION; TORSADE DES POINTES; CHEMICALLY INDUCED DISORDER; DOSE RESPONSE; DRUG APPROVAL; DRUG EFFECT; DRUG LABELING; DRUG UTILIZATION; EVIDENCE BASED MEDICINE; HEART MUSCLE CONDUCTION SYSTEM; LONG QT SYNDROME; PATHOPHYSIOLOGY; SAFETY; UNITED STATES;

ANTIEMETICS; CONSUMER PRODUCT SAFETY; DOSE-RESPONSE RELATIONSHIP, DRUG; DROPERIDOL; DRUG APPROVAL; DRUG LABELING; DRUG UTILIZATION; EVIDENCE-BASED MEDICINE; HEART CONDUCTION SYSTEM; HUMANS; LONG QT SYNDROME; POSTOPERATIVE NAUSEA AND VOMITING; TORSADES DE POINTES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 42449099549     PISSN: 00032999     EISSN: None     Source Type: Journal    
DOI: 10.1213/ane.0b013e31816ba463     Document Type: Article

References (36)

1. White PF, Watcha MF. Postoperative nausea and vomiting: prophylaxis versus treatment. Anesth Analg 1999;89:1337-9
2. Watcha MF. The cost-effective management of postoperative nausea and vomiting. Anesthesiology 2000;92:931-3
3. Bailey P, Norton R, Karan S. The FDA droperidol warning: is it justified? Anesthesiology 2002;97:288-9
4. Habib AS, Gan TJ. Food and drug administration black box warning on the perioperative use of droperidol: a review of the cases. Anesth Analg 2003;96:1377-9
5. Habib AS, Gan TJ. The use of droperidol before and after the Food and Drug Administration black box warning: a survey of the members of the Society of Ambulatory Anesthesia. J Clin Anesth 2008;20:35-9
6. Bailey P, White PF. Droperidol editorial: making a mountain out of a mole hill! Anesthesiology 2003;99:760-1
7. Gan TJ, White PF, Scuderi PE, Watcha MF, Kovac A. FDA "black box" warning regarding use of droperidol for postoperative nausea and vomiting: is it justified? Anesthesiology 2002;97:287
8. White PF. Droperidol: a cost-effective antiemetic for over thirty years. Anesth Analg 2002;95:789-90
9. Parlow JL, Costache I, Avery N, Turner K. Single-dose haloperidol for the prophylaxis of postoperative nausea and vomiting after intrathecal morphine. Anesth Analg 2004;98:1072-6
10. Buttner M, Walder B, von Elm E, Tramer MR. Is low-dose haloperidol a useful antiemetic?: a meta-analysis of published and unpublished randomized trials. Anesthesiology 2004;101:1454-63
11. Lee Y, Wang PK, Lai HY, Yang YL, Chu CC, Wang JJ. Haloperidol is as effective as ondansetron for preventing postoperative nausea and vomiting. Can J Anaesth 2007;54:349-54
12. Aouad MT, Siddik-Sayyid SM, Taha SK, Azar MS, Nasr VG, Hakki MA, Zoorob DG, Baraka AS. Haloperidol vs. ondansetron for the prevention of postoperative nausea and vomiting following gynaecological surgery. Eur J Anaesthesiol 2007;24:171-8
13. Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac A, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramer MR, Vander Kolk G, Watcha M. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg 2007;105:1615-28
14. Fortney JT, Gan TJ, Graczyk S, Wetchler B, Melson T, Khalil S, McKenzie R, Parrillo S, Glass PS, Moote C, Wermeling D, Parasuraman TV, Duncan B, Creed MR. A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups. Anesth Analg 1998;86:731-8
15. Henzi I, Sonderegger J, Tramer MR. Efficacy, dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vomiting. Can J Anaesth 2000;47:537-51
16. Habib AS, El-Moalem HE, Gan TJ. The efficacy of the 5-HT(3) receptor antagonists combined with droperidol for PONV prophylaxis is similar to their combination with dexamethasone. A meta-analysis of randomized controlled trials. Can J Anaesth 2004;51:311-9
17. Leslie JB, Gan TJ. Meta-analysis of the safety of 5-HT3 antagonists with dexamethasone or droperidol for prevention of PONV. Ann Pharmacother 2006;40:856-72
18. Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med 2004;350:2441-51
19. Nuttall GA, Eckerman KM, Jacob KA, Pawlaski EM, Wigersma SK, Marienau ME, Oliver WC, Narr BJ, Ackerman MJ. Does low-dose droperidol administration increase the risk of drug-induced QT prolongation and torsade de pointes in the general surgical population? Anesthesiology 2007;107:531-6
20. Michalets EL, Smith LK, Van Tassel ED. Torsade de pointes resulting from the addition of droperidol to an existing cytochrome P450 drug interaction. Ann Pharmacother 1998;32:761-5
21. Abe K, Takada K, Yoshiya I. Intraoperative torsade de pointes ventricular tachycardia and ventricular fibrillation during sevoflurane anesthesia. Anesth Analg 1998;86:701-2
22. Daley MD, Norman PH. Torsade de pointes ventricular tachycardia during, but not necessarily caused by, sevoflurane anesthesia. Anesth Analg 1998;87:981
23. Deem S. Sevoflurane and torsade de pointes. Anesth Analg 1998;87:981-2
24. Lischke V, Behne M, Doelken P, Schledt U, Probst S, Vettermann J. Droperidol causes a dose-dependent prolongation of the QT interval. Anesth Analg 1994;79:983-6
25. Guy JM, Andre-Fouet X, Porte J, Bertrand M, Lamaud M, Verneyre H. [Torsades de pointes and prolongation of the duration of QT interval after injection of droperidol]. Ann Cardiol Angeiol (Paris) 1991;40:541-5
26. White PF, Song D, Abrao J, Klein KW, Navarette B. Effect of low-dose droperidol on the QT interval during and after general anesthesia: a placebo-controlled study. Anesthesiology 2005;102:1101-5
27. Charbit B, Albaladejo P, Funck-Brentano C, Legrand M, Samain E, Marty J. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron-.[see comment]. Anesthesiology 2005;102:1094-100
28. Chan MT, Choi KC, Gin T, Chui PT, Short TG, Yuen PM, Poon AH, Apfel CC, Gan TJ. The additive interactions between ondansetron and droperidol for preventing postoperative nausea and vomiting. Anesth Analg 2006;103:1155-62
29. Sun Y, Habib AS, Candiotti KA, Viscusci E, Gan TJ. Effect of adenosine on the QTc interval during general anesthesia. Anesthesiology 2007;107:A1701
30. Kasinath NS, Malak O, Tetzlaff J. Atrial fibrillation after ondansetron for the prevention and treatment of postoperative nausea and vomiting: a case report. Can J Anaesth 2003;50:229-31
31. Baguley WA, Hay WT, Mackie KP, Cheney FW, Cullen BF. Cardiac dysrhythmias associated with the intravenous administration of ondansetron and metoclopramide. Anesth Analg 1997;84:1380-1
32. Bosek V, Hu P, Robinson LA. Acute myocardial ischemia after administration of ondansetron hydrochloride. Anesthesiology 2000;92:885-7
33. Haddad PM, Anderson IM. Antipsychotic-related QTc prolongation, torsade de pointes and sudden death. Drugs 2002;62:1649-71
34. Funck-Brentano C, Jaillon P. Rate-corrected QT interval: techniques and limitations. Am J Cardiol 1993;72:17B-22B
35. Luo S, Michler K, Johnston P, Macfarlane PW. A comparison of commonly used QT correction formulae: the effect of heart rate on the QTc of normal ECGs. J Electrocardiol 2004;37(suppl):81-90
36. Charbit B, Samain E, Merckx P, Funck-Brentano C. QT interval measurement: evaluation of automatic QTc measurement and new simple method to calculate and interpret corrected QT interval. Anesthesiology 2006;104:255-60