Saxagliptin and Alogliptin Safety Communication

April 5, 2016

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, they 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.

Healthcare professionals and patients are encouraged to report any adverse events or side effects related to the use of this product and/or quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:  Complete and submit the report online: www.fda.gov/MedWatch/report.htm  Complete and return a form by mail (address on the pre-addressed form) or fax (1-800-FDA-0178). [Call 1-800-332-1088 to request a reporting form or download a form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.]

Source: http://www.fda.gov/Drugs/DrugSafety/ucm486096.htm

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