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FDA Pulls Zofran 32 mg due to Potential For Serious Cardiac Risks

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Washington, DC: The Food and Drug Administration (FDA) is pulling the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) from the US market because of the potential for serious cardiac risks.

The 32 mg, single IV dose of Zofran had been used to prevent chemotherapy-induced nausea and vomiting. A previous Drug Safety Communication (DSC), issued on June 29, 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm. These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers.

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