FDA takes closer look at AZ’s saxagliptin

The regulator says a 2013 study that indicated a higher rate of heart failure compared to placebo—but not death—has prompted a second look at the diabetes medication.

Deborah Weinstein

February 11, 2014

4:02 pm

Onglyza

The FDA is looking into a possible association between type 2 diabetes medication saxagliptin and heart failure. The drug was not associated with a higher risk of death.

Saxagliptin, also known as Onglyza and Kombiglyze XR, was initially part of a Bristol-Myers Squibb/AstraZeneca alliance. AZ took full ownership of products from the now-former joint venture late last year.

The regulator announced the investigation Tuesday, citing a study in the New England Journal of Medicine published in 2013 that found that more saxagliptin patients were hospitalized for heart failure than were placebo group patients.

Saxagliptin was not linked with a higher rate of stroke, which was another study endpoint.

The FDA said in a statement that it is not advising patients to stop using saxagliptin, nor is it asking doctors to stop prescribing the DPP-4 medication.

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