Canada Boosts Reglan Movement Disorder WarningsJul 22, 2011 | Parker Waichman LLP
Reglan (metoclopramide) is getting stronger warnings on the risk of a movement disorder known as "tardive dyskinesia." Canadian drug regulators announced earlier this week. The current prescribing information for Reglan and generic equivalents contains information on this risk, but Health Canada said it is working with Canadian manufacturers on more detailed warnings.
Reglan is used short-term to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief of symptoms. The drug works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines.
Tardive dyskinesia is characterized by uncontrollable muscle movements, mainly in the face, tongue, mouth or jaw. These movements can include lip smacking, chewing, or puckering, or sticking out of the tongue. Sometimes, movements can include the torso or limbs, such as leg shaking. There are no known treatments for tardive dyskinesia once it has become established. The risk increases with longer treatment and is higher in the elderly, especially elderly women.
In 2009, the U.S. Food & Drug Administration (FDA) mandated that the makers of Reglan and other metoclopramide products add a boxed warning to their labels regarding the risk of tardive dyskinesia associated with chronic, long-term use. The FDA's mandate followed the publication of analyses that suggested that metoclopramide is the most common cause of drug-induced movement disorders.
The new Canadian Reglan warnings will contain the following information:
- Tardive dyskinesia may develop in patients treated with metoclopramide. The elderly, especially elderly women, appear to be at increased risk.
- The risk appears to increase with treatment length and the total amount of drug taken.
- Tardive dyskinesia is more likely to be irreversible with long-term treatment (over 12 weeks).
- Less frequently, tardive dyskinesia can develop with short term treatment at low doses; in these cases, the symptoms are more likely to disappear either partially or completely over time, once treatment has been stopped.
- Tardive dyskinesia may not be easy to recognize in its early stages.
- Metoclopramide treatment beyond 12 weeks should be avoided, unless the benefit is judged to outweigh the risk.
Health Canada also reminded healthcare professionals that Reglan and other brands of metoclopramide are not approved in Canada for treating diabetic gastroparesis (partial paralysis of the stomach), nausea and vomiting in pregnancy, or for symptoms of bloating or constipation associated with eating disorders.