New warnings on medications containing saxagliptin, alogliptin

New warnings will be placed on saxagliptin and alogliptin about the potential risk of heart failure, particularly in patients with heart or kidney disease, the FDA announced on April 5.


New warnings will be placed on saxagliptin and alogliptin about the potential risk of heart failure, particularly in patients with heart or kidney disease, the FDA announced on April 5.

Saxagliptin and alogliptin are dipeptidyl peptidase-4 (DPP-4) inhibitors and are found in the following medications: Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin extended release), Nesina (alogliptin), Kazano (alogliptin and metformin), and Oseni (alogliptin and pioglitazone). The FDA recommends that clinicians consider discontinuing medications that contain saxagliptin and alogliptin in patients who develop heart failure, making sure to monitor their diabetes control, according to a safety alert.

An FDA safety review concluded that the drugs may increase the risk of heart failure based on 2 large clinical trials conducted in patients with heart disease, which showed that more patients who received saxagliptin- or alogliptin-containing medications were hospitalized for heart failure than patients who received placebo. One trial showed that 3.5% of patients receiving saxagliptin were hospitalized for heart failure compared to 2.8% of patients receiving placebo. The alogliptin trial showed that 3.9% of patients treated with the drug were hospitalized for heart failure versus 3.3% in the placebo group.

See our coverage in this issue of an earlier study examining cardiac risks of these drugs.