The FDA is notifying health care professionals that the single intravenous (IV) dose of Zofran (ondansetron HCl; GlaxoSmithKline) 32mg will no longer be marketed due to the potential for serious cardiac risks.
Earlier on June 29, 2012, the FDA warned that Zofran 32mg single IV dose should be avoided due to the risk of a QT interval prolongation, which can lead to Torsades de Pointes, a potentially fatal heart rhythm. These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers.
Zofran, a selective 5-HT3 receptor antagonist, is indicated in prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. It is also indicated for the prevention of post-op nausea and vomiting.
It is anticipated that these products will be removed from the market through early 2013. Removal of IV Ondansetron 32mg sold as pre-mixed injections is not anticipated to contribute to a drug shortage. Oral dosing of Ondansetron remains effective for the prevention of chemotherapy-induced nausea and vomiting.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm330772.htm.