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Domperidone is associated with an increased risk of sudden cardiac death and ventricular arrhythmia compared to nonuse
Background: Domperidone
Domperidone, mosapride, or itopride use is associated with an increased risk of severe VA
1 Introduction
The overall GRADE rating is moderate
Background: Domperidone is widely prescribed in patients with gastrointestinal disorders but some cardiac adverse effects have been recently reported
1-5 These studies also suggest the increased risk is observed
(2) In a case-control study domperidone was associated with an estimated relative risk of sudden cardiac death of 3
As a result, the CPMs were further updated in 2015 to include a maximum daily dose recommendation, and new restrictions for use in patients with certain medical conditions or taking other drugs
Domperidone should be used at the lowest effective dose for the shortest possible duration
The cardiac risks of domperidone have been well described and as a result, it is possible that clinicians prescribed metoclopramide to patients who they deemed at high risk of cardiac arrhythmia
Recently, discussion on the safety of domperidone has arisen because an association with sudden cardiac death has been suggested
This unfortunate step was taken without considering the fact that the cardiac side effects occurred only when the drug was taken intravenously by otherwise very sick patients
• The benefit-risk balance of domperidone remains positive in the relief of the symptoms of nausea Background: Recently, a 4-fold increase in risk of sudden cardiac death (SCD) was reported for domperidone in a study that focused on corrected QT interval (QTc)-prolonging drugs as a class and their association with SCD
The MARC concluded that while the balance of benefits and risk of harms for domperidone remains favourable there is a small increased risk of adverse heart effects
The agency already has two separate safety alerts both on domperidone and the risk of “serious abnormal heart rhythms and sudden death (cardiac arrest)” issued in 2012 and 2015
Methods Data from nine studies involving 101,155 patients were used for the analysis of CV event risk, while data from eight studies involving 390 patients were used for the