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

se of Reglan. 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.

Because the risk of tardive dyskinesia may be greatest in patients who have taken Reglan or metoclopramide for an extended period, the FDA required a warning stating that chronic use of the drugs should be avoided, except in rare cases. According to the drug’s label, Reglan should only be prescribed for short-term use of four to 12 weeks. The safety of Reglan and metoclopramide use for longer than 12 weeks has not been studied.

“Tardive dyskinesia is a debilitating disease which substantially alters the quality of one’s life. It may affect thousands who used Reglan or metoclopramide,” says Shamus B. Mulderig, Managing Attorney of the Pharmaceutical and Medical Device Litigation Department at Hissey Kientz, LLP. “Tardive dyskinesia is a horrible affliction, is not reversible and has no cure. And because the FDA’s Adverse Event Reporting System is a voluntary reporting system, the number of reports received so far may seriously understate how widespread this affliction may be.”

Reglan is also linked to a serious and potentially fatal syndrome known as Neuroleptic Malignant Syndrome (NMS). Symptoms of NMS include hyperthermia, muscle rigidity, altered consciousness, irregular pulse, blood pressure or heartbeat or other symptoms.

An analysis conducted by the FDA found that, at a minimum, 20% of patients taking the drugs did so for longer than the three month maximum set by the
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Analysis of FDA Adverse Events Data Reveals at Least 106 Serious Conditions Reported Among Reglan Users
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