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32-mg Zofran Recalled for Cardiac Risks


December 4, 2012 — More than one year after the U.S. Food and Drug Administration (FDA) first warned about the deadly cardiac risks associated with 32-mg Zofran (ondansetron), an anti-nausea drug, the agency has just published a Safety Communication to announce a recall. The FDA expects that the drug will no longer be marketed by early 2013. The recall does not affect lower doses of Zofran.

The FDA first warned about the cardiac risks of Zofran in September 2011. Although the label already warned about the risk of irregular heart rhythm, the FDA required GlaxoSmithKline (GSK) to place a warning about QT interval prolongation, which could interfere with electrical activity in the heart and cause a potentially fatal condition called Torsades de Pointes.

After the update, the FDA also required GSK to conduct a study to determine what dose of Zofran was associated with QT interval prolongation. The study found that 32-mg intravenous Zofran was linked to serious cardiac risks.

The Zofran recall is not expected to affect very many patients — fewer than 1% of patients are given 32-mg intravenous Zofran. The drug is typically used to control nausea and vomiting after surgery or during chemotherapy.

The FDA also issued the following recommendation:

“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.”


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