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LETTER TO EDITOR
Year : 2020  |  Volume : 11  |  Issue : 1  |  Page : 69-70  

Ondansetron and arrhythmia: An adverse effect, medical error, or insufficient guidelines


Pediatric Ward, Sevome Shaban Hospital, Tehran, Iran

Date of Submission14-Feb-2019
Date of Decision29-Mar-2019
Date of Acceptance06-May-2020
Date of Web Publication20-Jul-2020

Correspondence Address:
Dr. Majid Malaki
Sevome Shaban Hospital, Tehran
Iran
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpnr.JPNR_2_19

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How to cite this article:
Malaki M. Ondansetron and arrhythmia: An adverse effect, medical error, or insufficient guidelines. J Pharm Negative Results 2020;11:69-70

How to cite this URL:
Malaki M. Ondansetron and arrhythmia: An adverse effect, medical error, or insufficient guidelines. J Pharm Negative Results [serial online] 2020 [cited 2020 Aug 11];11:69-70. Available from: http://www.pnrjournal.com/text.asp?2020/11/1/69/290202



Sir,

Ondansetron is the most frequently administered antiemetic in emergency medicine, but most adverse effects related to ondansetron have been reported in operation rooms and emergency wards by slowly infusion of single intravenous dose of 4 mg that can be associated with different forms of fatal arrhythmia such as bradycardia, ventricular tachycardia, and atrial fibrillation that occurred during 2–15 min after receiving drug.

[1],[2] Arrhythmia following ondansetron may also be reported by intramuscular route, but it seems that such catastrophic events may partly be related to a coincidence underlying situations such as fatal infections due to an intra-abdominal sepsis misleading us to ondansetron side effect.[3] Ondansetron arrhythmia may be seen in all ages as low as 86th day or in a 10-year-old boy who received multiple doses of ondansetron beside to morphine for a disease such as gastroenteritis in outpatient prescription.[4] Getting drug and medical history that prolong QT interval is basic before ondansetron prescription especially by intravenous form because of there is not any report about arrhythmia following use of single oral ondansetron administration.[1] the renewed Food and Drug Administration (FDA) recommendation in 2012 confirmed the risk of QT prolongation with single dose of 32 mg ondansetron if be administered by intravenous method. FDA recommends the intravenous regimen of 0.15 mg/kg (not exceeded 16 mg per dose) can be administered every 4 h for three doses.[5] Our evidences show this recommendation is inadequate in clinical practice because of ondansetron may be dangerous in values as low as 2 mg in adults that is too lower than FDA recommendation, especially in co administrating with some medications such as metoclopramide.[6] It is time to find the lowest effective dose of ondansetron similar to an study on children affected to gastroenteritis; it has been shown that ondansetron as low as 0.13 mg/kg can be effective to control of vomiting and higher dose cannot give more clinical benefits.[7] In another study that performed in healthy persons, it has been shown that 1 mg ondansetron can effectively prevent nausea and vomiting after operation.[8] Most of the reports about arrhythmia following ondansetron did not hint the quality of administration such as defining dose in mg/kg, concentration of drug in compatible solutions and infusion rapidity rate, but all fatally events occurred in a few minutes or immediately after infusion. With regard that we know that maximum rate of QT interval occur within 20 minutes, a time that can be flexible and depends on patients medical condition and prescription dose and this time may be delayed up to 120 minutes after receiving drug. There are also other influencing factors on ondansetron adverse effects occurrence such as the quality of hepatic metabolism and ageing that prolong ondansetron half life up to 5.5 h in older people (age over 75) that should be kept in mind.[9] All these pharmacologic truth should reform our policy about ondansetron that infusion rate should be done over 20 min or more in at least effective dose.

In conclusion, ondansetron is a safe and effective drug in practice; most of fatal arrhythmia following ondansetron is related to medical error due to insufficient guidelines and ignorance about patients' medical history and consider vomiting as a disease not as a symptom. Ondansetron in doses as low as 0.15 mg/kg slowly infusion over a prolonged time that should be introduced in a comprehensive guideline with strict monitoring is reasonable and can be lifesaving.

Acknowledgment

I dedicate this study to my leader Dr. Mohammad Mosadegh. God bless his soul.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Freedman SB, Uleryk E, Rumantir M, Finkelstein Y. Ondansetron and the risk of cardiac arrhythmias: A systematic review and postmarketing analysis. Ann Emerg Med 2014;64:19-25.  Back to cited text no. 1
    
2.
Afonso N, Dang A, Namshikar V, Kamat S, Rataboli PV. Intravenous ondansetron causing severe bradycardia: Two cases. Ann Card Anaesth 2009;12:172-3.  Back to cited text no. 2
    
3.
Chandrakala R, Vijayashankara CN, Kumar KK, Sarala N. Ondansetron induced fatal ventricular tachycardia. Indian J Pharmacol 2008;40:186-7.  Back to cited text no. 3
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4.
Brenner SM, Boucher J. Fatal cardiac arrest in 2 children: Possible role of Ondansetron. Pediatr Emerg Care 2016;32:779-84.  Back to cited text no. 4
    
5.
U.S. Food and Drug Administration. FDA Safety Communication: Abnormal Heart Rhythms May Be Associated with Use of Zofran (Ondansetron). Available from: http://www.fda.gov/Drugs/Drug Safety/ucm271913.htm. [Last accessed on 2015 Oct 26].  Back to cited text no. 5
    
6.
Baguley WA, Hay WT, Mackie KP, Cheney FW, Cullen BF. Cardiac dysrhythmias associated with the intravenous administration of ondansetron and metoclopramide. Anesthesia Analgesia 1997;84:1380-1.  Back to cited text no. 6
    
7.
Moeller JR, Gummin DD, Nelson TJ, Drendel AL, Shah BK, Berger S. Risk of ventricular arrhythmias and association with ondansetron. J Pediatr 2016;179:118-230.  Back to cited text no. 7
    
8.
Gupta SD, Pal R, Sarkar A, Mukherjee S, Mitra K, Roy S, et al. Evaluation of Ondansetron-induced QT interval prolongation in the prophylaxis of postoperative emesis. J Nat Sci Biol Med 2011;2:119-24.  Back to cited text no. 8
    
9.
Hafermann MJ, Namdar R, Seibold GE, Page RL 2nd. Effect of intravenous ondansetron on QT interval prolongation in patients with cardiovascular disease and additional risk factors for Torsades: A prospective, observational study. Drug Healthc Patient Saf 2011;3:53-8.  Back to cited text no. 9
    




 

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