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Anti-Nausea Drug, Zofran to be Removed from the Market

Filed December 5th, 2012 admin

The U.S. Food and Drug Administration (FDA) is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed due to the drug’s potential for serious cardiac risks.

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

The FDA said it anticipates these products will be removed from the market by early 2013. The agency does not anticipate that this will contribute to a drug shortage of IV ondansetron as the 32 mg dose makes up a very small percentage of the current market.

The FDA continues to recommend the intravenous regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. Oral dosing of ondansetron remains effective for the prevention of chemotherapy-induced nausea and vomiting, the agency said. The FDA currently has no recommendation on an alternative single IV dose regimen.

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