SFDA limits the use of Domperidone to low dosages and minimal periods in treatment of nausea

SFDA launched an alert to  healthcare practitioners and patients, clarifying that they studied the relation between using Domperidone product and causes of serious side effects e.g. sudden cardiac death and ventricular fibrillation. 

SFDA said, ” After reviewing drug safety of this product and escalating the matter to the concerned professional committees at SFDA, it is found that there is a possibility of occurrence of these side effects, especially when the drug is used in big dosages and for long periods.”

Based on these results, SFDA has limited the use of Domperidone to the treatment of nausea and vomiting only, for short periods and in low dosages and short periods, provided that the dosage for adolescents and adults weighing over 35 kg. shall not exceed 10mg./3 times daily orally, or 30 mg./2 times daily through the an,us for a period of one week.

SFDA emphasized prohibition of using Domperidone for patients with history of heart failure or stokes or heartbeats irregularity. SFDA reinforced that it is tracking and following up all updated information in the field of drug safety and security in the Kingdom and encouraged healthcare practitioners and patients to report any drug side effects to the National Center for Pharmacovigilence & Drug Safety. 

It is noteworthy that Domperidone is registered in the Kingdom under the following names: Motilium, Dompy, Prokinin, Amistop and Mododom