|LETTER TO EDITOR
|Year : 2020 | Volume
| 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 Submission||14-Feb-2019|
|Date of Decision||29-Mar-2019|
|Date of Acceptance||06-May-2020|
|Date of Web Publication||20-Jul-2020|
Dr. Majid Malaki
Sevome Shaban Hospital, Tehran
Source of Support: None, Conflict of Interest: None
|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
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.
, 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. 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. 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. 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. 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. 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. In another study that performed in healthy persons, it has been shown that 1 mg ondansetron can effectively prevent nausea and vomiting after operation. 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. 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.
I dedicate this study to my leader Dr. Mohammad Mosadegh. God bless his soul.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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