FDA Reviewing Heart Failure Risk Linked to Diabetes Drug

The US Food and Drug Administration (FDA) has requested clinical trial data from the manufacturer of saxagliptin to investigate the diabetes drug's potential association with heart failure (HF).

The US Food and Drug Administration (FDA) has requested clinical trial data from the manufacturer of saxagliptin to investigate the diabetes drug’s potential association with heart failure (HF).

The agency’s request follows the publication of a study in the September 2013 issue of the New England Journal of Medicine that reported an increased rate of HF hospitalization among type 2 diabetes patients taking the dipeptidyl peptidase-4 inhibitor to lower their high blood sugar, compared to those taking a placebo. However, the study did not find an increased rate of death or other major cardiovascular risks — including heart attack or stroke — among type 2 diabetes patients who received saxagliptin.

The FDA expects AstraZeneca, which markets saxagliptin as Onglyza and Kombiglyze XR, to submit the clinical trial data by early March 2014. Until the evaluation of that data is completed, the FDA has advised healthcare professionals to “continue to follow the prescribing recommendations in the drug labels.” The agency instructed patients to continue taking saxagliptin, but also discuss their concerns with healthcare providers.