The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. The Zofran (ondansetron) drug labels already contain information about the potential for QT prolongation. Additional label changes may result after the additional information has been reviewed. The results from this study are expected to be available in the summer of 2012. The manufacturer of Zofran (GlaxoSmithKline) is being required to conduct a thorough QT study to assess the potential for the drug to prolong the QT interval. Patients at particular risk for developing Torsade include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.įDA has reviewed all available information and is making interim changes to the drug labels. Also available as an injection for intravenous use (2 mg/mL).Ĭhanges in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram ) - see Data Summary below - can lead to an abnormal and potentially fatal heart rhythm (including Torsade de Pointes). Available as 4 mg and 8 mg tablets, 4 mg and 8 mg orally disintegrating tablets, and oral solution (4 mg/5 mL).Works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting. Is in a class of medications called 5-HT3 receptor antagonists.Used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery.Facts about Zofran (ondansetron and ondansetron hydrochloride)
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