Reglan Movement Disorder Warnings Strengthened in Canada

Canadian health officials are requiring stronger warnings about the risk of movement disorders from Reglan, which is sold as generic metoclopramide.

The new metoclopramide warnings were announced by Health Canada on July 20, providing additional information about the link between long-term use of Reglan and an increased risk of tardive dyskinesia, which is associated with repetitive and involuntary movements, particularly involving the lower face and limbs.

The gastrointestinal drug will now carry the following warnings in Canada:

• 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 recognise in its early stages.
• Metoclopramide treatment beyond 12 weeks should be avoided, unless the benefit is judged to outweigh the risk.

Reglan (metaclopramide) is designed for short-term treatment of gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, it is often prescribed for longer periods of time due to the often chronic persistence of those ailments, which has left many users with the movement disorder.

Symptoms of tardive dyskinesia can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment for the socially debilitating disorder, and the involuntary movements can be permanent, persisting even after use of the drug has stopped.

In the United States, more than 1,000 lawsuits over Reglan have been filed in courts throughout the United States against manufacturers of metoclopramide, alleging that drug makers failed to adequately warn about the risk of tardive dyskinesia and other movement disorders from Reglan. However, a Supreme Court decision issued earlier this month may result in the dismissal of many of those cases, as most have been filed against the manufacturers of generic Reglan.

In a 5-4 decision issued on last month, the U.S. high court ruled that generic drug manufacturers can not be held liable for failing to warn about known drug side effects, since federal regulations require that the warning label for generic medications be identical to those carried on the name brand medication.