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:
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
- 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.
StelNovember 5, 2011 at 3:39 pm
This was an outstanding article. Thank you so much for taking time to write it. My mother-in-law has developed TD and all the awful symptons that go along with it after years of being on Metoclopramide. We are trying to wade our way through the medical information available. I am disgusted that any doc would prescribe a drug for a stomach ailment that as early as 1999 was associated with so many[Show More]This was an outstanding article. Thank you so much for taking time to write it. My mother-in-law has developed TD and all the awful symptons that go along with it after years of being on Metoclopramide. We are trying to wade our way through the medical information available. I am disgusted that any doc would prescribe a drug for a stomach ailment that as early as 1999 was associated with so many side effects (ascertained that from the fact that the article attached to your write-up--written by the atty and the doc--was dated 1999). While we've yet to be able to obtain all of her medical records, it appears she was on the drug for years. Anyway, superb article. Thank you!
BethJuly 23, 2011 at 6:32 pm
Want to read an article that describes the dozens of symptoms in Plain English? http://www.reflux.org/reflux/webdoc01.nsf/%28vwWebPage%29/EPS-TD.htm?OpenDocument I'm the author. I wrote this for patients and got it published in a medical journal.
"*" indicates required fields
More Top Stories
With thousands of Bard hernia mesh lawsuits pending in the federal court system, a fourth bellwether trial will be held in the spring, involving allegations that defects with Bard 3DMax caused painful and permanent injuries.
A Tepezza hearing loss lawsuit accuses the manufacturer of failing to warn doctors to conduct hearing tests, which could have helped a woman avoid permanent hearing damage.
A South Dakota man has filed one of the first gastroparesis lawsuits against Ozempic manufacturers, alleging that users have not been adequately warned about the risk of severe vomiting and long-term stomach side effects.