GSK's Zofran Could Lead To Abnormal Heart Rhythms: FDA

Law360, Chicago (September 16, 2011, 4:54 PM EDT) -- Use of GlaxoSmithKline PLC's anti-nausea drug Zofran and its generic equivalents may boost the risk of developing abnormal and potentially fatal heart rhythms, the U.S. Food and Drug Administration announced Thursday.

The FDA said it was conducting an ongoing safety review of the drug, used to prevent nausea and vomiting caused by chemotherapy, radiation therapy and surgery, and that the agency was making interim changes to the drug's labels.

GSK must also conduct its own study to determine whether Zofran might affect the electrical activity of...
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