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FDA Requires Black Box Warning For GI Drug

Law360 (February 26, 2009, 12:00 AM EST) -- The U.S. Food and Drug Administration said Thursday that it would require a black box warning for metoclopramide, a drug used to treat gastrointestinal disorders that has been found to cause muscle spasms and tics.

The black box warning will alert long-term and high-dose users of metoclopramide about the risks of developing tardive dyskinesia, which is characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements, puckering and pursing of the lips, and impaired movement of the fingers.

These symptoms...
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