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  • FDA Date: 04/05/2016

    Saxagliptin and Alogliptin FDA Drug Safety Communication

    FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin

    This is an update to the FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR) issued on February 11, 2014.

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    A U.S. Food and Drug Administration (FDA) safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs. As a result, we are adding new warnings to the drug labels about this safety issue.

    Saxagliptin and alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Untreated, type 2 diabetes can lead to serious health problems, including blindness, nerve and kidney damage, and heart disease.

    Patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure such as:

    • Unusual shortness of breath during daily activities
    • Trouble breathing when lying down
    • Tiredness, weakness, or fatigue
    • Weight gain with swelling in the ankles, feet, legs, or stomach

    Patients should not stop taking their medicine without first talking to their health care professionals.

    Health care professionals should consider discontinuing the medicine in patients who develop heart failure and monitor their diabetes control. If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.

    View the full FDA Drug Safety Communication on FDA.gov