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Metoclopramide Nausea

On February, 26, 2009, the FDA announced that Baxter Healthcare Corporation, the maker of Reglan, must add a ‘black box warning’ to their drug labels warning of the risk of the drug’s long-term and/or high-dose use. This ‘black box warning’ is the FDA’s strongest warning apparatus and sends up a flag to both potential and current patients as well as physicians. This warning occurred due to the devastating syndrome known as tardive dyskinesia, which presents with involuntary and repetitive movements of the body, including rapid eye movements and blinking, puckering and pursing of the lips, grimacing, lip smacking, tongue protrusion and impaired movement of the fingers. These symptoms usually continue even after Oral Metoclopramide has been discontinued, although symptoms may somewhat lessen. The elderly population is especially at risk for developing this demoralizing and socially disabling syndrome.

Reglan and its generic, metoclopramide, is only approved for the short-term use (four to twelve weeks) to treat GERD (gastroesophogeal reflux disease), diabetes gastroparesis and delayed gastric emptying and severe nausea and vomiting associated with chemotherapy.