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Analysis of FDA Adverse Events Data Reveals at Least 106 Serious Conditions Reported Among Reglan Users
Date:5/8/2009

An analysis of the Food and Drug Administration’s Adverse Event Reporting System has identified at least 106 cases of tardive dyskinesia or other movement disorders reported among users of Reglan or its generic version, metoclopramide. Tardive dyskinesia is a neurological disorder characterized by involuntary, repetitive movements of the extremities, including 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.

(Vocus) May 8, 2009 -- An analysis of the Food and Drug Administration’s Adverse Event Reporting System has identified at least 106 cases of tardive dyskinesia or other movement disorders reported among users of Reglan or its generic version, metoclopramide.

Reglan and metoclopramide were approved by the FDA only for short-term treatment of certain gastrointestinal conditions, such as gastroesophageal reflux disease or diabetic gastroparesis. However, the manufacturers of these drugs derive substantial profit from their long-term use. The drugs work by speeding up the movement of the stomach muscles, which helps to increase the rate at which food moves from the stomach to the intestines.

In February 2009, the FDA forced the manufacturers of Reglan and metoclopramide to add a “black-box” warning to their labels about the strong connection between tardive dyskinesia and the long-term u
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