New restrictions have been put in place in Europe on medications containing metoclopramide, which is most commonly known by the brand name Reglan, removing high doses of the drug from the market and seeking to limit use due to neurological health risks associated with the medication.
On July 26, the European Medicines Agency (EMA) issued a press release announcing that it’s Committee on Medicinal Products for Human Use (CHMP) recommended changes to all drugs containing metoclopramide, which is commonly used to treat nausea.
Once sold under the brand name Reglan, the medication is now available only as a generic. Side effects of Reglan have been linked to neurological problems, including a rare movement disorder known as tardive dyskinesia, which may sometimes leave patients with permanent problems that continue even after the medication is no longer used.
The recommendations call for metoclopramide-based drugs to only be prescribed for short-term use of five days or less, and calls for the drug to only be prescribed for adults following chemotherapy, radiotherapy, surgery and the management of migraines. The committee also recommends that it only be given to children over one year of age and then only to prevent nausea and vomiting from chemotherapy. Even then, the committee determined that generic Reglan should only be used if other drugs are unavailable, can’t be tolerated or prove ineffective.
Reglan is approved for the short-term treatment of gastrointestinal disorders, such as diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, it has often been prescribed for longer periods of time due to the often chronic persistence of those ailments.
In the United States, the FDA required the manufacturers of all medications containing metoclopramide to update the warning label in February 2009, providing information that users may face an increased risk of tardive dyskinesia when the medications are used at high doses or for a long period of time.
Symptoms of tardive dyskinesia can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the socially debilitating disorder, and the involuntary movements can be permanent, persisting even after use of the drug has stopped.
The CHMP recommendations must now be approved by the European Commission. If they are approved they would be adopted throughout the European Union.