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Black Box Warning for Reglan Tardive Dyskinesia More Than a Year Old

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Washington, DCThe Internet is abuzz this week with news that the US Food and Drug Administration (FDA) has implemented a black box warning for Reglan and all other drugs containing metoclopramide. A black box warning is the strongest spanner the FDA has in its toolbox short of asking a manufacturer to remove a product from the market entirely.

What's curious about the buzz is that Reglan's black box warning is over a year old. According to an FDA press release dated February 26, 2009, the boxed warning and risk mitigation strategy for Reglan and metoclopramide-containing drugs was released in early 2009. There are no recent releases on the official FDA website pertaining to Reglan.

In its original release, the FDA suggested that published analyses determined that metoclopramide is the most common cause of drug-induced involuntary movement disorders.

"Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months," says the release. "The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months."

Tardive dyskinesia is characterized by involuntary movement of facial muscles, the tongue, the eyes, fingers and other extremities. The risk for drug-induced tardive dyskinesia can begin at any age. In some cases the tardive dyskinesia stops when the patient stops taking the drug—but not always.

Metoclopramide (Reglan) was approved by the FDA for the treatment of gastroesophageal reflux disease or diabetic gastroparesis on a short-term basis only. The risk is heightened when Reglan therapy is maintained for longer than 12 weeks.


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