Drug Information Center

College of Pharmacy

FDA removes ondansetron 32 mg products from the US market

In June 2012, the US Food and Drug Administration (FDA) issued a drug safety communication regarding the risk of QT prolongation with a single high dose (32 mg/ 50 mL) of intravenous (IV) ondansetron for chemotherapy-induced nausea and vomiting.  QT prolongation is a heart rhythm abnormality that can lead to a potentially fatal arrhythmia.  Because of the serious nature of this side effect, in December 2012 the FDA decided remove the high dose ondansetron product from the US market.  Other formulations of IV ondansetron (2 mg/mL, 4 mg/2 mL, and 40 mg/20 mL) and oral ondansetron products will not be affected.

For prevention of chemotherapy-induced nausea and vomiting, the FDA recommends 3 doses of ondansetron 0.15 mg/kg IV every 4 hours.  This is similar to the American Society of Clinical Oncology guideline recommendation of ondansetron 8 mg or 0.15 mg/kg.  Dosing decisions for prevention of chemotherapy-induced nausea and vomiting should be made after considering relevant patient- and medication-related factors.

The FDA announcement regarding the market removal of 32 mg ondansetron can be found here:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ ucm330772.htm?source=govdelivery

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