FDA Warns GSK’s Zofran May Cause Abnormal Heart Rhythm

Law360, New York (June 29, 2012, 4:28 PM EDT) -- Results from a study on GlaxoSmithKline PLC's anti-nausea drug Zofran and its generic equivalents suggest that some intravenous use may affect the heart's electrical activity, leading to patients developing an abnormal, potentially fatal heart rhythm, the U.S. Food and Drug Administration said Friday.

The FDA said the clinical study revealed that a 32-milligram single intravenous dose of Zofran may prolong the heart's so-called QT interval — the length of time between certain waves in the heart's electrical cycle — which can lead to a serious and...
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