Reglan Adverse Events More Than Doubled from 20...( Recent data ...),Health

Recent data from the Food and Drug Administration’s Adverse Event Reporting System reveals that new cases of tardive dyskinesia or other movement disorders reported by users of Reglan (or its generic version, metoclopramide) more than doubled between 2006 and 2008. 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 use of Reglan.

Austin, Texas (Vocus) July 7, 2009 -- Recent data from the Food and Drug Administration’s Adverse Event Reporting System reveals that new cases of tardive dyskinesia or other movement disorders reported by users of Reglan (or its generic version, metoclopramide) more than doubled between 2006 and 2008, according to an analysis by Hissey Kientz, LLP. This represents a substantial increase in new adverse events related to Reglan.

“Another very striking aspect of this increase in Reglan-related side effects cases is that these were reported to the FDA before manufacturers were even requested to add a ‘black-box’ warning to the drugs’ labels,” says Shamus B. Mulderig, an attorney with Hissey Kientz, LLP. “As the agency begins to release data collected after this February’s warning notice was issued, and more patients and physicians become aware of the life-altering side eff
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