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FDA panel recommends label changes for Nesina

April 16, 2015

An FDA advisory panel recommended label changes for the diabetes drug Nesina after results from a cardiovascular outcomes trial revealed an increased risk for heart disease.

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-3 Tuesday in favor of including new safety information for Nesina (alogliptin, Takeda Pharmaceuticals). The recommendation follows EMDAC review of the results of the EXAMINE trial, which found an increase in the rate of hospitalization for heart failure in patients who were assigned the drug.

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