FDA to Investigate Saxagliptin for Possible Heart Failure Risk
Marketed as Onglyza and Kombiglyze XR, appears to have no effect on heart attack or stroke risk
TUESDAY, Feb. 11, 2014 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday that it will investigate possible links between the diabetes drug saxagliptin and a heightened risk for heart failure among users.
In a statement, the agency said that the probe was spurred by "a study published [last September] in the New England Journal of Medicine, which reported an increased rate of hospitalization for heart failure." The NEJM study did not find that saxagliptin had any effect on a patient's risk for heart attack or stroke.
However, "our data also show an increase in hospitalization for heart failure in patients who received saxagliptin, which was not expected and deserves further study," study chairman Eugene Braunwald, M.D., of Brigham and Women's Hospital and Harvard Medical School in Boston, said in a news release issued by the hospital when the study was published. The research involved nearly 16,500 patients with type 2 diabetes from 26 countries. It was funded by drug makers AstraZeneca and Bristol-Myers Squibb, which market saxagliptin.
The FDA said the information gleaned from the NEJM trial is considered "preliminary." The drug's makers now have until early March to submit detailed trial data to agency officials, "after which we will conduct a thorough analysis and report our findings publicly." In the meantime, the agency said that "patients should not stop taking saxagliptin and should speak with their health care professionals about any questions or concerns."