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| | | ![]() FDA Approves Metoclopramide Rapid Dissolving Tablets for Diabetic Gastroparesis, GERD NEW YORK -- September 8, 2009 -- The US Food and Drug Administration (FDA) has granted marketing approval for metoclopramide HCl (MetozolV ODT) 5mg and 10mg orally disintegrating tablets for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short–term therapy (4–12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. “[Metoclopramide HCl] is the first available treatment for both diabetic gastroparesis and symptomatic documented GERD that offers physicians and patients the similar safety and efficacy of metoclopramide with the added convenience of an orally disintegrating tablet formulation,” said Ronnie Fass, MD, University of Arizona, Phoenix, Arizona. “Patients with diabetic gastroparesis and symptomatic documented GERD may have trouble adhering to treatment because of difficulty swallowing, the need for treatment when they do not have water available, or the need for a portable way to take medication. Metoclopramide HCl, which rapidly melts on the tongue, gives these patients a new choice that may be more convenient than traditional metoclopramide tablets.” Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. In clinical studies, the most frequently reported adverse events (>= 2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting. SOURCE: Salix Pharmaceuticals
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