Higher Zofran Dose May Cause Patient Heart Problems

The FDA released a safety communication for the drug Zofran, which could pre-dispose patients to develop a potentially fatal heart rhythm known as Torsades de Pointes, according to the American Society of Anesthesiologists.

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Preliminary results from a clinical study of Zofran, or ondansetron, showed a 32 mg single intravenous dose may affect the electrical activity of the heart.

GlaxoSmithKline, the makers of Zofran, will change the drug label to remove the 32 mg single intravenous dose. The new label will suggest a lower intravenous dose, not to exceed 16 mg.

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

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