FDA has placed a black box warning (the strongest FDA warning) on all drugs containing the pharmaceutical ingredient metoclopramide (Reglan), which is used in the treatment of disorders like heartburn caused by gastroesophageal reflux disease.
The black box label warns consumers about the risk of developing tardive dyskinesia, which causes involuntary repetitive momements (twitches) with long-term, high-dose use of metoclopramide. Symptoms of tardive dyskinesia can persist long after the patient stops using the drug.
Metoclopramide can be found in Reglan tablets, oral disintegrating pills, metoclopramide oral solution and Reglan injections. All of these metoclopramide-containing prescription drugs already contain box warnings, but the seriousness of the risk of developing tardive dyskinesia (involuntary movements) will now be highlighted by the FDA’s strongest available warning.
Any patient taking Reglan or other forms of metoclopramide should have been warned of the risk of tardive dyskinesia by their doctor prior to being prescribed the drug. The risk increases the longer a patient takes metoclopramide, and with higher doses. FDA studies show that around 20 percent of patients who developed drug-induced movement disorders after taking Metoclopramide had taken the drug for more than three months.
The FDA encourages consumers to report adverse events to the FDA’s MedWatch program. You can reach MedWatch by phone at 800-FDA-1088.
