Drug Safety Alert
Domperidone related Serious Cardiac Events in Children under 12 years of age!
European Medicines Agency (EMA) and the National Agency for the Safety of Medicines and Health Products (ANSM) France, have confirmed the risk of serious adverse cardiac events associated with the use of Domperidone including QT prolongation, torsade de pointes, ventricular arrhythmias and sudden cardiac death. The use of Domperidone is now restricted to adults and adolescents over 12 years of age and weighing 35kg or more. The recommended maximum dose is 30mg/day. The duration of treatment should be as short as possible. All Healthcare Professionals are advised to monitor patients taking Domperidone and caution should be observed in patients. In case such event is observed, please report to PDCU through mss.Punjab.gov.pk/
Primary & Secondary Healthcare Department,
Govt. of the Punjab