A GlaxoSmithKline (NYSE:GSK) anti-nausea drug used by cancer patients is now under a Food and Drug Administration safety review studying possible heart risks.
The FDA said that it is reviewing Zofran (ondansetron and ondansetron hydrochloride) and its generics. The agency said these drugs may increase the risk of abnormal electrical activity, in turn leading to a potentially abnormal heart rhythm.
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Zofran is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. It works by blocking the action of the hormone serotonin. London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, received FDA approval for Zofran in 1991. The drug’s patent protection expired in 2006.
The FDA is making interim changes to Zofran’s drug labels and GSK has been directed to conduct additional studies. Results are expected by next summer.
