FDA to Add Heart Failure Warnings to DPP-4 Type 2 Diabetes Medications

Washington, DC 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, according to a recent safety review by the US Food and Drug Administration (FDA).

Saxagliptin (Onglyza, Kombiglyze XR) and alogliptin (Nesina, Kazano, Oseni) 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 announced that as a result of the findings, it will be adding new warnings to the labels on all saxagliptin- and alogliptin- containing medications.

The findings are from an FDA evaluation of two large clinical trials conducted in patients with heart disease. Each trial showed that more patients were hospitalized for heart failure who received saxagliptin- or alogliptin-containing medicines compared to patients who received placebo.

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 translates to 35 out of every 1,000 patients compared to 28 out of every 1,000 patients, respectively. 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, which translates to 39 out of every 1,000 patients compared to 33 out of every 1,000 patients, respectively.

In addition to adding warnings to these medication labels, the FDA is recommending that health care professionals consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control.