Drug Safety Alerts

Diabetes Medicines Containing Saxagliptin and Alogliptin

4/05/2016


On April 5, 2016, the United States Food and Drug Administration (FDA) issued a drug safety communication stating 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.

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

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. The FDA evaluated two large clinical trials conducted in patients with heart disease. These clinical trials were also discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo (see Data Summary in the FDA Drug Safety Communication for additional information). In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo. This is the same as 35 out of every 1,000 patients compared to 28 out of every 1,000 patients. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group. This is the same as 39 out of every 1,000 patients compared to 33 out of every 1,000 patients.

The FDA has provided the following information for health care providers:

• 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 and alogliptin-containing Medicines).

• Risk factors of hospitalization for heart failure include a history of heart failure or renal impairment, and this safety risk was found in clinical trials among patients with these medical issues.

• Consider the risk and benefits of saxagliptin or alogliptin prior to initiating treatment in patients at a higher risk for heart failure.

• Observe patients receiving saxagliptin or alogliptin for signs and symptoms of heart failure.

• If heart failure develops, consider discontinuing the drug and monitor diabetes control. If blood sugar level is not well-controlled with a patient’s current treatment, other diabetes medicines may be required.

• Encourage patients to read the Medication Guide they receive with their prescriptions.

• Report adverse events involving saxagliptin, alogliptin, or other medicines to the FDA MedWatch program.

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.

For more information about the drug safety communication, health care providers may contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov/Drugs/DrugSafety.