The use of metoclopramide may lead to extrapyramidal symptoms in children, according to a Health Canada-endorsed letter to health care professionals from Sandoz Canada Inc., Apotex Inc., Omega Laboratories and Pendopharm Division of Pharmascience Inc. Metoclopramide is used treat delayed gastric emptying and small bowel movements.
Health Canada conducted a safety review analyzing the neurological side effects associated with metoclopramide use in children, and found that “Extrapyramidal symptoms may occur in children receiving the daily recommended dose of metoclopramide that should not exceed 0.5 mg/kg”. The review also led to two new contraindications; the drug should not be used in children younger than one year because the risks outweigh the benefits nor should it be used in children older than one year of age unless the expected benefits clearly outweigh the risks.
The letter, dated Jan. 5, 2015, stated “The Canadian Product Monographs for metoclopramide drugs were revised recently to include the new contraindication and restrictions on the use of metoclopramide in children.”
Health Canada urges any adverse events to be reported, stating that “Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.”
“Any case of serious neurological adverse events or other serious or unexpected adverse reactions in patients receiving APO-Metoclop, Metoclopramide Hydrochloride Injection, Metoclopramide Omega or METONIATM should be reported to Apotex Inc., Sandoz Canada Inc., Omega Laboratories Limited and Pendopharm Division of Pharmascience Inc., respectively or Health Canada. “ the letter said.