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Reglan, Similar Heart Burn Drugs to Have Black Box For Movement Disorder

Feb 27, 2009 | Parker Waichman LLP

Heart burn drugs that contain metoclopramide, including Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution and Reglan Injection, will now be labeled with a Black Box that warns of their link to a movement disorder.  According to the Food & Drug Administration (FDA), Reglan and other metoclopramide-containing drugs can cause a neurological problem called tardive dyskinesia when they are taken in high doses, or  over a long period of time.

According to the FDA, more than 2 million people use Reglan and other metoclopramide drugs.  The medications are meant for the  short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies.  The are also used to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines). Treatment with such medications is not supposed to exceed three months, the FDA said.

The new Black Box Warning is being added to the label of metoclopramide-containing drugs because recently published analyses suggest that metoclopramide is the most common cause of drug-induced 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. The FDA said it 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, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

According to the FDA, the current  labeling for Reglan and similar drugs warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. In addition to the new Black Box - the agency's strongest safety warning - the FDA is also requiring the makers of metoclopramide-containing drugs to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses the dangers of using these medications in high doses, or over a long period of time.

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