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FDA to put warning labels on two AstraZeneca drugs

Delaware Public Media

The FDA this week announced that it will tack new warning labels on certain kinds of type 2 diabetes drugs, including those produced by Wilmington-based AstraZeneca.

A safety review by the federal agency found that medicines containing saxagliptin may increase the risk of heart failure, especially in patients who already have heart or kidney disease.

Two diabetes medications produced by AstraZeneca contain this drug, Onglyza and Kombiglyze XR.

The FDA made its decision after looking at data from two large clinical trials conducted in patients with heart disease. One study found that patients being treated with Onglyza were much more likely to be hospitalized for heart failure than those who were not.

The agency began examining saxagliptin for this health risk more than two years ago. And an advisory committee last year also recommended that a warning label be applied to saxagliptin.

AstraZeneca reported that Onglyza made $786 million in sales during fiscal year 2015, down by more than $30 million compared to sales in 2014. But sales for the drug did see a slight uptick in the most recent quarter.


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