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Medication Safety Alerts

Diabetes Medicines Containing Saxagliptin and Alogliptin


On April 5, 2016, the United States Food and Drug Administration (FDA) issued a drug safety communication stating that that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in those who already have heart or kidney disease.

A list of medicines affected by this issue is provided here:

The FDA has provided the following information for members:

  • The FDA has added warnings about the risk of hospitalization for heart failure to the labels of saxagliptin- and alogliptin-containing type 2 diabetes medicines (see List of saxagliptin or alogliptin-containing Medicines). Heart failure occurs when the heart cannot pump enough blood to meet the body’s needs.
  • Before taking saxagliptin or alogliptin, tell your doctor if you have a history of heart failure or kidney impairment, as an increased risk of hospitalization for heart failure was found in clinical trials that included patients with these medical issues.
  • Do not stop taking your saxagliptin or alogliptin medicine without first talking to your doctor.
  • Contact your doctor right away if you develop signs and symptoms of heart failure when taking saxagliptin or alogliptin, 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
  • Read the patient Medication Guide you receive with your prescriptions. It explains the benefits and risks associated with the use of the medicine.
  • Talk to your doctor if you have any questions or concerns about saxagliptin or alogliptin.

Report side effects from saxagliptin, alogliptin, or other medicines to the FDA

CVS/caremark Response: There have been no recalls issued on these products by their manufacturers because of this action. CVS/caremark Mail Service Pharmacy will continue to dispense these products.

If you are currently taking type 2 diabetes medicines containing saxagliptin and alogliptin and have questions, please call your doctor or call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their website at

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