Zofran Label Updated Over Safety Concerns

The Food and Drug Administration issued a safety warning for the anti-nausea drug Zofran (ondansetron) due to the potential risk of abnormal heart rhythm at certain dosages.

Preliminary results from a recent clinical study suggests that a 32 mg intravenous dose of Zofran or its generics may affect the electrical activity of the heart, which could cause patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes, according to an FDA press release.

The drug’s manufacturer GlaxoSmithKline (GSK) announced changes to the Zofran label to remove the 32 mg single intravenous dose. The updated label will state that ondansetron can be used in adults and children at the lower intravenous dose recommended in the drug label. However, no single intravenous dose should exceed 16 mg.

The FDA will evaluate the final study results when available and it will work with GSK to explore an alternative single dose regimen that is both safe and effective for the prevention of chemotherapy-induced nausea and vomiting in adults.

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