High-Dose Zofran (ondansetron) Pulled From Market

High-Dose Zofran Pulled From Market

WASHINGTON -- The 32-mg dose of the anti-nausea drug ondansetron (Zofran) has been pulled from the market because of concerns about cardiac problems, the FDA announced Tuesday.
Ondansetron is approved for preventing chemotherapy-induced nausea and vomiting, and, in lower doses, for postoperative nausea and vomiting. The 32-mg formulation is given as a single intravenous dose.
"FDA does not anticipate that removal of the 32-mg intravenous dose of ondansetron currently sold as pre-mixed 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," the agency said in a statement.
In June, the FDA warned that the 32-mg dose should be avoided due to the risk of QT interval prolongation, which can lead to torsades de pointes, a potentially fatal arrhythmia.....