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Health Canada Warns of Severe Side Effects in Young Children Taking Reglan

Filed January 6th, 2015 Laurie

Health Canada has issued several directives for the use of metoclopramide (Reglan) in very young children.

Health Canada Warns of Severe Side Effects in Young Children Taking Reglan

Health Canada Warns of Severe Side Effects in Young Children Taking Reglan

Extrapyramidal symptoms are drug-induced side effects that include a number of atypical involuntary muscle contractions that affect gait, movement and posture, according to Reglan is used for the treatment of delayed gastric emptying and small bowel intubation.

Health Canada wrote that it completed a safety review on neurological adverse events in children receiving Reglan within the daily recommended dosage. The review concluded the following:

-Extrapyramidal symptoms may occur in children receiving the daily recommended dose of Reglan that should not exceed 0.5 mg/kg.

-Reglan is now contraindicated in children less than 1 year of age as they appear to be at greater risk of extrapyramidal symptoms.

-Reglan should not be used in children older than 1 year of age unless the anticipated benefits clearly outweigh the potential risks.

In a public communication issued January 5, Health Canada also warned that parents should not use Reglan in children greater than 1 year of age without talking to the child’s doctor. Additionally, parents who notice abnormal involuntary movements in their child or have any questions about their child’s treatment with the drug should contact their child’s doctor.

In early 2009, the U.S. Food and Drug Administration (FDA) ordered the maker of Reglan to add a boxed warning about the risk of tardive dyskinesia, a disorder that causes repetitive, involuntary movements like facial tics; lip smacking, pursing and puckering; facial grimacing; tongue protrusion; rapid eye movements or blinking; impaired movements of the fingers and restless leg syndrome (RLS). Tardive dyskinesia is often a permanent condition, even if a patient stops taking Reglan.

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