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FDA Warns Anti-Nausea Drug May Cause Abnormal Heart Beat

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An ongoing safety review of anti-nausea medication Zofran (ondansetron, ondansetron hydrochloride, and their generics) is underway due to links to abnormal heartbeat. The U.S. Food and Drug Administration (FDA) notes that Zofran might increase risks for developing abnormal changes in the heart’s electrical activity, which can result in a potentially fatal abnormal heart rhythm.

Changes in the electrical activity of the heart, known as prolongation of the QT interval of the electrocardiogram [ECG], can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. Patients at specific risk for developing Torsade include those with underlying heart conditions such as congenital long QT syndrome, those predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.

ECG changes including QT interval prolongation have been seen in patients receiving Zofran (ondansetron). Torsade de Pointes has been reported in some patients receiving ondansetron.

Zofran is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery and is part of a medication class called 5-HT3 receptor antagonists. Zofran works by blocking the action of serotonin—a natural substance that may cause nausea and vomiting—and is available in 4 and 8 mg tablets; 4 and 8 mg orally disintegrating tablets; a 4 mg/5 mL oral solution; and a 2 mg/mL injection for intravenous use.

The agency has reviewed available data and is in the process of making interim drug label changes. GlaxoSmithKline, the maker of Zofran, is being mandated to conduct a complete QT study to determine the Zofran’s potential to prolong the QT interval. Study results are expected next summer, which may result in additional label changes.

Today, Zofran (ondansetron) labels contain information about the potential for QT prolongation, but will be revised to include a warning to avoid Zofran use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. The new labels will also contain recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.

The FDA recommends that patients do not stop taking Zofran (ondansetron) without first speaking to their healthcare professionals and that patients be aware that, while taking Zofran, physicians might order an electrocardiogram (ECG, EKG) to monitor heart rate and rhythm.

If an irregular heartbeat, shortness of breath, dizziness, or fainting is experienced while taking Zofran (ondansetron), a physician should be immediately contacted and side effects should be reported to the FDA MedWatch program.

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