The U.S. Food and Drug Administration said it has asked AstraZeneca Plc. to provide clinical trial data from saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. The FDA said it made the request because of a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure 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 heart attack or stroke, in patients who received saxagliptin.
The agency said it expects AstraZeneca to submit the trial data by early March 2014, after which the FDA said will conduct a thorough analysis and report its findings publicly.
"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," the FDA said in a release. "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."
The FDA said it is urging health care professionals and patients to report side effects involving saxagliptin products to the FDA MedWatch program.