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Health Canada Updates Reglan Labels to Warn of Tardive Dyskinesia

By August 8, 2011July 10th, 2019Uncategorized

Health Canada is informing health professionals and consumers about changes being made on Reglan labeling. The new labels will warn the public about the drug’s risk of causing tardive dyskinesia.

Tardive dyskinesia symptoms are a lot like Parkinson’s disease in that it causes sufferers to experience uncontrollable movements in the extremities as well as lip smacking, grimacing, uncontrollable eye movements and blinking. The condition also can cause restless leg syndrome.

Reglan has been used in Canada since 1975 and is generally prescribed to treat digestive problems that occur when the stomach empties too slowly. The drug works by speeding up the breakdown of foods in the digestive system. In the U.S., it is mostly used to treat acid reflux (GERD). In 2009, the FDA advised that the drug not be used for a period of longer than 12 weeks because it can increase the chances of patients suffering from adverse side effects like TD.

Right now, Canadian labeling does point out the risks of tardive dyskinesia, but Health Canada is seeking to work with drug manufacturers to make the warning more strenuous. This is likely due to the thousands of lawsuits that have been filed against drug manufacturers amid claims that they were not properly forewarned of the side effects when given the drug for periods longer than the FDA-recommended 12 weeks. For patients that are already suffering from TD, which there is no cure for, this warning came too late.

According to information posted on, “Health care professionals are reminded that metoclopramide has not been approved in Canada for the treatment of hiccups, diabetic gastroparesis (partial paralysis of the stomach), nausea and vomiting in pregnancy, or for symptoms of bloating or constipation associated with eating disorders. Metoclopramide is available in various strengths and forms, including as a solution for injection, or as liquid or tablets that can be taken by mouth. It is sold under generic names only.”