FDA Investigates Link Between Diabetes Drug and HF

The U.S. Food and Drug Administration (FDA) announced that it is investigating the type 2 diabetes drug saxagliptin (Onglyza) due to a possible link to heart failure (HF). The SAVOR-TIMI 53 trial, which found a significant increase of hospitalization for HF in patients taking the drug, sparked the investigation and the FDA wants to see all the data from the trial. The FDA noted that the clinical trial did not find higher rates of death or other major cardiovascular events in patients taking saxagliptin. "At this time, we consider information from the NEJM study to be preliminary," the FDA said. "Our analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk."

Read the full FDA Drug Safety Communication.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Adamantane, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Dipeptides, Heart Failure, Hospitalization, Risk Factors, United States Food and Drug Administration

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