The U.S. Food & 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 its potential association with serious cardiac risks.
The 32 mg, single IV dose of Zofran had been used in the prevention of chemotherapy-induced nausea and vomiting and is sold, pre-mixed, in solutions of either dextrose or sodium chloride in plastic containers.
A prior Drug Safety Communication (DSC), issued on June 29, 2012, stated that the 32 mg, single IV dose of Zofran should be avoided over risks for a specific type of irregular heart rhythm called QT interval prolongation. QT interval prolongation can lead to Torsades de Pointes, which is an abnormal, potentially fatal heart rhythm.
The agency said it anticipates these Zofran products will be removed from the market through early 2013 and does not anticipate that removal of these 32 mg intravenous dose of ondansetron, which are currently sold as pre-mixed injections, will contribute to a drug shortage of IV ondansetron. The 32 mg dose comprises a very small percentage of the current market, according to the FDA.
The FDA said it 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. Also, oral dosing of ondansetron remains effective for the prevention of chemotherapy-induced nausea and vomiting.
The FDA pointed out that, at this time, there is insufficient available information for the agency to recommend an alternative single IV dose regimen.
Healthcare professionals and patients 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: Complete and submit the report online at www.fda.gov/MedWatch/report.htm; download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1.800.332.1088 to request a reporting form, then complete and return the form to the address on the pre-addressed form, or submit the form by fax to 1.800.FDA.0178.