FDA’s request resulted from a study published in the New England Journal of Medicine ( NEJM ), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of Saxagliptin ( marketed as Onglyza and Kombiglyze XR ) compared to an inactive treatment.
The study did not find increased rates of death or other major cardiovascular risks, including myocardial infarction or stroke, in patients who received Saxagliptin.
The manufacturer is expected to submit the trial data to FDA by early March 2014, after which FDA will conduct a thorough analysis.
At this time, FDA considers information from the NEJM study to be preliminary. Analysis of the Saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.
Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. It works by increasing the amount of insulin produced by the body after meals, when blood sugar is high.
Patients should not stop taking Saxagliptin and should speak with their health care professionals about any questions or concerns.
Health care professionals should continue to follow the prescribing recommendations in the drug labels. ( Xagena )
Source: FDA, 2014