The U.S. Food and Drug Administration (FDA) is informing the public of an ongoing safety review of the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and their generics). Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm (including Torsade de Pointes).
Patients at particular risk for developing Torsade include those with conditions like congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in their blood, and those taking other medications that lead to QT prolongation.
The manufacturer of Zofran (GlaxoSmithKline) is being required to conduct a thorough QT study for further assessment. The results from this study are expected to be available during the summer of 2012. Afterward, additional label changes may occur. Currently, the labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade.
Additionally, recommendations for ECG monitoring in patients with electrolyte abnormalities (i.e. low potassium, calcium, or sodium), congestive heart failure, slow heart rate, or in patients taking other medications that can lead to QT prolongation, are being included in the labels.
* Do not stop taking Zofran (ondansetron) without talking to your healthcare professional;
* Discuss any questions or concerns about Zofran (ondansetron) with your healthcare professional;
* While taking Zofran (ondansetron), your healthcare professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm;
* Seek immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking Zofran (ondansetron);
* Report any side effects you experience to the FDA MedWatch program.
Learn more at http://www.fda.gov/Drugs/DrugSafety/ucm271913.htm
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