The FDA announced that it was adding safety warnings to the labels of medications that are intended to treat type 2 diabetes and contain saxagliptin and alogliptin.
An FDA safety review found that the drugs might increase the risk of heart failure in some patients, particularly those with known heart or kidney disease.
The warning applies to the following medications: Onglyza (saxagliptin); Kombiglyze RX (saxagliptin and metformin extended release); Nesina (alogliptin); Kazano (alogliptin and metformin); and Oseni (alogliptin and pioglitazone). The drugs are dipeptidyl peptidase-4 (DPP-4) inhibitors.
The FDA evaluated two trials that showed more patients who received saxagliptin- or alogliptin-containing medications were hospitalized compared with patients who received a placebo.
In one trial, 3.5 percent of patients who received saxagliptin and 2.8 percent of patients who received placebo were hospitalized for heart failure. In the other trial, 3.9 percent of patients who received alogliptin and 3.3 percent of patients who received placebo were hospitalized for heart failure.
The FDA recommends that healthcare professionals should consider discontinuing medications that contain saxagliptin and alogliptin in patients who develop heart failure. If patients cannot control their blood sugar, the FDA said they might consider taking other diabetes medications.