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New Warnings Issued for Zofran Heart Risks

Filed July 3rd, 2012 Laurie

A safety alert issued by the Food and Drug Administration warns that a drug used to treat nausea in cancer patients can cause an irregular heart rhythm when given to patients in certain doses.

British drug maker GlaxoSmithKline recommended to the FDA that the removal of the 32 milligram, single intravenous dose of Zofran from its product label, according to a spokesman. The agency is reviewing the company’s recommendation before deciding to accept it or reject it.

The drug Zofran can cause an abnormal and potentially fatal heart rhythm called Torsades de Pointes in patients by affecting the electrical activity of the heart.

The drug maker said it was updating oncologists about the withdrawn dosage in a letter to healthcare providers scheduled to be released next week.

Zofran (ondansetron) is part of a class of medications referred to as 5-HT3 receptor antagonists. It helps prevent nausea, along with vomiting caused by chemotherapy, radiation, and surgery.
The FDA said it will explore an alternative single dose regimen with GSK for the same indication.

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