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FDA issues drug safety communication about heart risks with ondansetron
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Preliminary study results suggest a 32-mg single IV dose of ondansetron may affect QT prolongation, which could predispose patients to develop torsades de pointes, a type of ventricular tachycardia.
The FDA is informing health care professionals and the public about this potential risk, and manufacturer
GlaxoSmithKline announced that the drug label will no longer recommend a 32-mg single dose.
Ondansetron (Zofran) is a 5-HT3 receptor antagonist used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. Patients who may be at particular risk for QT prolongation with ondansetron include those with congenital long QT syndrome, congestive heart failure or bradyarrhythmias, as well as those patients who take concomitant medications that prolong the QT interval.
The updated label will state that ondansetron can still be used in adults and children with chemotherapy-induced nausea and vomiting, but at a lower IV dose of 0.15 mg/kg administered every 4 hours for three doses, according to a press release. The label also will note that no single IV dose should exceed 16 mg, as well as new information from the clinical study.
The FDA will evaluate the final study results when they are available and will work with GlaxoSmithKline to explore an alternative single-dose regimen that is both safe and effective for the prevention of chemotherapy-induced nausea and vomiting in adults, according to the release.