GSK Anti-Nausea Drug Zofran Under FDA Review

GSK (GlaxoSmithKline) anti-nausea cancer drug Zofran is under review by the Food and Drug Administration, the agency reported Thursday.

Zofran (ondansetron, ondansetron hydrochloride and their generics) is used to prevent nausea and vomiting caused by cancer treatments, including chemotherapy and radiation therapy, by blocking the action of the hormone serotonin, which causes nausea. It belongs to a class of drugs called 5-HT3 receptor antagonists.

GSK received FDA approval for Zofran in 1991, and the drug’s patent protection expired in 2006. London-based GSK has its U.S. headquarters in Research Triangle Park, N.C.

The FDA announced Zofran may cause abnormal electrical activity. This could lead to a potentially fatal abnormal heart rhythm known as Torsade de Pointes, especially in those with underlying heart conditions or who are predisposed to low blood levels of potassium and magnesium, and those taking certain other medications.

The FDA is making changes to Zofran’s drug labels. GSK has been instructed to conduct additional studies of the drug, from which results are expected next summer.

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