FDA Warns That GlaxoSmithKline’s Zofran May Increase Risk of Certain Heart Problems

Zofran (ondansetron) may increase the risk of developing abnormal changes in the electrical activity of the heart, the Food and Drug Administration said Sept. 15.

Zofran is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery, the agency 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, including Torsade de Pointes, FDA said.

Patients at particular risk for developing Torsade include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to ...