Drug Information Update – New Drug Safety Communication on saxagliptin and alogliptin.

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

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 (see List of saxagliptin- and alogliptin-containing Medicines).

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.

For more information, please visit: saxagliptin and alogliptin