FDA investigating link between saxagliptin and heart failures

February 12, 2014

FDA has announced it is reviewing a possible link between heart failures and the popular diabetes drug saxagliptin, which AstraZeneca markets as Onglyza and Kombiglyze XR.

FDA has announced it is reviewing a possible link between heart failures and the popular diabetes drug saxagliptin, which AstraZeneca markets as Onglyza and Kombiglyze XR.

FDA said it has requested data from clinical trials after the New England Journal of Medicine published a study that showed a rise in hospitalizations for heart failures for patients using saxagliptin.

The study did not find an increase in deaths or other major cardiovascular risks in patients who received saxagliptin. FDA said it asked for the trial data to be submitted by early March.

“At this time, we consider information from the NEJM study to be preliminary. Our analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk,” FDA said on its website. “Patients should not stop taking saxagliptin and should speak with their healthcare professionals about any questions or concerns. Healthcare professionals should continue to follow the prescribing recommendations in the drug labels.”

Saxagliptin is prescribed to lower blood sugar in adults with type 2 diabetes who are also advised to exercise and watch their diets.