Risk Alert: Ondansetron (Zofran) 32 mg, single intravenous (IV) dose — product removal

December 7th, 2012

The 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks.

Zofran is used to prevent chemotherapy-induced nausea and vomiting. A drug safety communication issued on June 29, 2012, warned that the 32 mg, single IV dose should be avoided due to the risk of QT interval prolongation, which can lead to Torsades de Pointes. These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers.

The FDA anticipates these products will be removed from the market through early 2013.  FDA does not anticipate that removal of the 32 mg intravenous dose of ondansetron currently sold as pre-mixed injections 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. At this time, there is not enough information available for FDA to recommend an alternative single IV dose regimen.

Health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

December 4 — FDA safety alert

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