FDA Issues New Warning for 5 Diabetes Drugs
The Food and Drug Administration (FDA) has reported that type 2 diabetes medications containing saxagliptin and alogliptin may increase the risk of heart failure especially in patients who already have cardiovascular or renal disease.
The FDA is adding new warnings to the affected drug labels about this new safety risk. Saxagliptin and alogliptin are dipeptidyl peptidase-4 (DPP-4) inhibitors that are indicated for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. In 2015, approximately 386,000 patients received a dispensed prescription for saxagliptin-containing products (saxagliptin and saxagliptin-metformin), and 56,000 patients received a dispensed prescription for alogliptin-containing products (alogliptin, alogliptin-pioglitazone, and alogliptin-metformin) from the U.S. outpatient retail pharmacy setting. The drugs impacted by this safety communication include:
- Onglyza (saxagliptin; AstraZeneca)
- Kombiglyze XR (saxagliptin/metformin ext-rel; AstraZeneca)
- Nesina (alogliptin; Takeda)
- Kazano (alogliptin/metformin; Takeda)
- Oseni (alogliptin/pioglitazone; Takeda)
The FDA reviewed two large trials conducted in patients with heart disease. Findings from each trial revealed that more patients who received saxagliptin- or alogliptin-containing drugs were hospitalized for heart failure vs. patients who received placebo. In one of the trials, SAVOR, 3.5% of patients who received saxagliptin were hospitalized for heart failure vs. 2.8% in the placebo group. In the second trial, EXAMINE, 3.9% of patients treated with alogliptin were hospitalized for heart failure vs. 3.3% in the placebo group. Risk factors for hospitalization heart failure include a history of heart failure or renal impairment.
Healthcare professionals should consider discontinuing saxagliptin- and alogliptin-containing treatments in patients who develop heart failure and should monitor their diabetes control. If the patient's blood glucose is not well-controlled with the current treatment, other diabetes treatments may be needed. The risks and benefits of saxagliptin or alogliptin therapy should be considered before initiating treatment in patients at high risk for heart failure.
For more information visit FDA.gov.