Ondansetron 32-mg dose pulled from market

The 32-mg, single intravenous dose of ondansetron hydrochloride (Zofran) has been pulled from the market due to its cardiac risks, the FDA recently announced.

The agency had previously warned that this dose of the anti-nausea drug should be avoided due to the risk of QT-interval prolongation, which can lead to torsades de pointes. Now, the pre-mixed 32-mg solutions, which also contain either dextrose or sodium chloride, are being recalled by the branded and generic manufacturers.

The FDA continues to recommend an intravenous regimen of 0.15 mg/kg administered every four hours for three doses to prevent chemotherapy-induced nausea and vomiting, but no single intravenous dose should exceed 16 mg, according to the agency's drug safety communication.