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Home , Droperidol

PRACTICE H EALTH AND D RUG A LERTS

Droperidol: cardiovascular toxicity and deaths

Reason for posting: Health Canada has inhibits α-adrenergic receptors, which darone), (), warned that the injectable form of leads to peripheral vasodilation (and some (amitrip- droperidol, commonly used as a neuro- possible ). It acts within tyline), antibiotics (erythromycin, keto- leptic and , has been associ- minutes of injection and has a half-life conazole, moxifloxacin or pentamidine), ated with 8 deaths in Canada.1 The of 2.2–10 hours depending on its route ( or terfena- drug is also commonly used intramus- of administration.4,8 As a neuroleptic it dine), (), arsenic cularly to treat migraine headache2 and has known adverse effects including se- (for leukemia treatment) or migraine to sedate combative patients3 including dation, (rest- therapies (). Droperidol children and adolescents.4 Worldwide, lessness, akathisia, and occulo- should not be given to people whose more than 60 cases of QT prolonga- gyric crises) and neuroleptic malignant baseline 12-lead electrocardiogram tion, serious cardiac arrhythmias (e.g., syndrome.6,7 Droperidol is to be avoid- (ECG) reveals a QTc interval greater [TdP]) and sudden ed in patients with or renal dis- than 440 ms for males and 450 ms for death have been reported in association ease, Parkinson’s disease or epilepsy.7 females. Injectable droperidol should be with injectable droperidol.1 One inter- Cardiovascular effects of the drug may used only in a hospital setting, where vi- national manufacturer, Janssen-Cilag, be due to delayed myocardial repolar- tal signs and ECG monitoring is avail- announced in March 2001 its discon- ization, with QT prolongation and in- able. The US manufacturer recom- tinuation of droperidol production after creased risk of TdP.5 QT prolongation mends 2–3 hours of cardiac monitoring chronic oral use of the drug by psychi- was apparently not mentioned in any of after administration;9 however, the ap- atric patients was found to be associated the reports of death in Canada, and propriate duration of monitoring is un- with fatal cardiac arrhythmias. In De- other were concurrently clear (arrhythmias and QT prolonga- cember 2001 the US Food and Drug being administered.1 tion have occurred up to 24 hours after Administration announced that the the drug’s administration), and it is un- warning labels for droperidol would be What to do: Patients should be screened clear whether continuous monitoring strengthened to recognize that cases of for a history of or risk factors for long will detect or prevent serious QT pro- TdP were occurring even at doses of QT syndrome. Patients predisposed to longation, arrhythmia and death.1 the drug below those recommended.5 QT prolongation and TdP include Health Canada is assessing whether those with electrolyte disturbances (low Eric Wooltorton further regulatory action regarding serum potassium or magnesium levels), Editorial Fellow, CMAJ droperidol is required in Canada.1 bradycardia, cardiac conduction distur- bances, congestive heart failure, cardiac References The drug: Droperidol is approved for hypertrophy, a history of abuse 1. Cardiovascular toxicity with injectable droperidol. Ottawa: Health Canada; 2002 Feb 12. Available: use in Canada as a neuroleptic drug and or recurrent blackouts, or a family his- www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english is an effective antiemetic for postopera- tory of sudden death. QT prolongation /advisory/tpd/droperidol_e.html (accessed 2002 6 Mar 5). tive nausea and nausea associated with may also be more common in people 65 2. Vinson DR. Treatment patterns of isolated be- Meniere’s disease.7 It is available in years and older and in those concomi- nign headaches in US emergency departments. Canada only in injectable forms. Dro- tantly using benzodiazepines, volatile Ann Emerg Med 2002;39(3):215-22. 3. Hick JL, Mahoney BD, Lappe M. Prehospital se- peridol is a and acts in anesthetics, intravenous opiates, anti- dation with intramuscular droperidol: a one-year part as a antagonist.6 It also arrhythmics (, sotalol or amio- pilot. Prehosp Emerg Care 2001;5(4):391-4. 4. Hameer O, Collin K, Ensom MHH, Lomax S. Evaluation of droperidol in the acutely agitated child or adolescent. Can J Psychiatry 2001;46(9):864-5. Canadian Adverse Reaction Newsletter 5. FDA strengthens warnings for droperidol [talk pa- Bulletin canadien des effets indésirables per]. Rockville (MD): US Food and Drug Admin- istration; 2001 Dec 6. Available: www.fda.gov/bbs To receive the Newsletter and health product Advisories by email, /topics/ANSWERS/2001/ANS01123.html (ac- cessed 2002 Mar 5). join Health Canada’s Health_Prod_Info mailing list. 6. Henzi I, Sonderegger J, Tramer MR. Efficacy, Go to www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/adr.html and click on "subscribe." dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vom- Inscrivez-vous à la liste Info_Prod_Santé de Santé Canada pour recevoir par iting. Can J Anaesth 2000;47(6):537-51. courriel le Bulletin et les Avis au sujet des produits de santé. Rendez-vous à l’adresse 7. Droperidol injection USP (2.5 mg/ml) neuroleptic- www.hc-sc.gc.ca/hpb-dgps/therapeut/htmlfrn/adr.html et cliquez sur « abonnement ». antiemetic [product monograph]. Boucherville (PQ): Sabex Inc; 1995 May 8. Report adverse reactions toll free to Health Canada 8. Sawyer CA, Baker AB, Ramzan I, Regaglia F. Droperidol elimination after cardiopulmonary Signaler sans frais des effets indésirables à Santé Canada bypass surgery. J Clin Pharmacol 1998;38:160-5. Tel./Tél. : 866 234-2345 • Fax/Téléc. : 866 678-6789 9. Important drug warning [droperidol]. Buffalo Grove (IL): Akorn Pharmaceuticals; 2001 Dec 5. Email/Courriel: [email protected] Available: www.fda.gov/medwatch/SAFETY /2001/inapsine.htm (accessed 2002 Mar 5).

932 JAMC • 2 AVR. 2002; 166 (7)

© 2002 Canadian Medical Association or its licensors