FDA Updates Public on Heart Risk Of GlaxoSmithKline’s Anti-Nausea Drug Zofran

The Food and Drug Administration June 29 announced that preliminary results from a recently completed clinical study suggest that a 32 milligram single intravenous dose of Zofran (ondansetron) may increase the risk of developing abnormal changes in the electrical activity of the heart.

Zofran is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.

FDA said changes in the electrical activity of the heart (prolongation of the QT interval of an electrocardiogram) can lead to an abnormal and potentially fatal heart rhythm known as Torsade de Pointes. In 2011, FDA announced it was conducting an ...