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Drug Alert: Metoclopramide in children

January 5, 2015

Sandoz Canada Inc., Apotex Inc., Omega Laboratories Limited and Pendopharm Division of Pharmascience Inc. in consultation with Health Canada, would like to inform you of important new safety information concerning the potential risk of abnormal involuntary movements of the body called extrapyramidal symptoms that have been reported in children treated with metoclopramide at a recommended dose. In Canada, metoclopramide is approved for the treatment of delayed stomach emptying and for medical procedures such as inserting a tube into the small bowel (called small bowel intubation). Abnormal involuntary movements called extrapyramidal symptoms may occur in children receiving the recommended dose of metoclopramide. Do not use metoclopramide in children less than one year of age as they appear to be at higher risk of extrapyramidal symptoms. Do not use metoclopramide in children greater than one year of age without talking to your doctor.