Domperidone warning: FDA alerts public to elevated risk of serious ventricular arrhythmia

The Food and Drug Administration (FDA) issued a public warning regarding the use of Domperidone, a dopamine antagonist with pro-kinetic and antiemetic properties. 

In its advisory on Feb. 1, the literature review revealed an association between Domperidone and an elevated risk of serious ventricular arrhythmias or sudden cardiac death.

The FDA's analysis identified a higher risk of serious ventricular arrhythmias in patients over 60 years old, those taking daily doses exceeding 30 mg (milligram), and individuals using Domperidone alongside QT (electrical activity)-prolonging drugs or CYP3A4 inhibitors. 

The agency said that the Philippine data reported "four cases" of suspected adverse reactions related to QT prolongation and irregular heartbeat out of 97 reports, all without fatal outcomes.

Additionally, it noted that approved indications for Domperidone in the Philippines include dyspeptic symptoms, gastroesophageal reflux, esophagitis, and nausea or vomiting induced by various causes. 

Healthcare professionals were urged to prescribe the lowest effective dose for the shortest duration, especially in older patients or those with a cardiac history.

Pharmacists were also advised to dispense Domperidone with caution, considering contraindications and cardiovascular effects.

The FDA said the recommended maximum daily dose is "30 mg or three tablets."

The FDA emphasized the importance of reporting adverse reactions and cardiac events related to Domperidone use.

Patients with heart problems or taking cardiac medications were urged to consult their healthcare providers before using Domperidone and to seek immediate medical attention if experiencing an irregular heartbeat.

Moreover, the FDA urged both healthcare professionals and the public to be vigilant about potential cardiac risks associated with Domperidone, promoting responsible use and reporting of adverse reactions.