Extrapyramidal reactions in children treated with metoclopramide

Aim. Metoclopramide is used worldwide for the treatment of nausea and vomiting. Our study provides an estimate of the risk of extrapyramidal symptoms in children using metoclopramide. Patients and Methods. In a surveillance program of adverse drug reactions, children hospitalised for neurological disorders (cases) or for other acute conditions (controls) were compared with regard to the use of metoclopramide. Results. Out of 930 children (407 cases and 523 controls), 13 were hospitalised for extrapyramidal symptoms. Nine children with extrapyramidal symptoms, and 3 of the 523 controls, had used metoclopramide for the treatment of nausea and vomiting associated with fever and/or influenza (odds ratio 390; 95% confidence interval 61-2807). Discussion. This study provides strong evidence for the role of metoclopramide in the occurrence of extrapyramidal symptoms in children and suggests a reconsideration of the benefit-risk profile of this drug in the treatment of minor conditions.