.png?width=200&height=94&name=PDR_stacked_purple%20(002).png)
FDA Date: 12/3/12
Zofran (ondansetron) Injection FDA Drug Safety Communication
Updated information on 32 mg intravenous Zofran (ondansetron) dose and premixed ondansetron products
FDA is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the antinausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks. This dose has been removed from the Zofran drug label. FDA is now working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to voluntarily recall them from the market. These drugs are sold premixed in solutions of either dextrose or sodium chloride in plastic containers.
A previous Drug Safety Communication (DSC), issued on June 29, 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm.
The 32 mg, single IV dose had been used to prevent chemotherapy-induced nausea and vomiting. As stated in the previous DSC, 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. If the calculated weight-based dose were to exceed 16 mg, the potential for prolonged QT interval would be greater; therefore, no single intravenous dose should exceed 16 mg. In addition, 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.
FDA anticipates these products to 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 premixed 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. According to sales distribution data, ondansetron IV 32 mg premixed bags accounted for less than 1% of ondansetron IV sales (vials, bags, etc.) from the manufacturers to retail and nonretail channels of distribution in the 12-month period ending in June 2012.