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Diabetes drugs containing saxagliptin (Onglyza) and alogliptin (Nesina) may increase the risk of heart failure, the FDA announced Tuesday.
The warning comes after an FDA advisory committee voted a year ago that new labeling information should be added to these two dipeptidyl peptidase-4 (DPP-4) inhibitors; the agency said the decision comes after evaluating two large clinical trials of patients with type 2 diabetes and heart disease who took the medications.
Labels for products containing saxagliptin and alogliptin will be revised accordingly.
The new warning does not apply to other DPP-4 inhibitors, including sitagliptin (Januvia) and linagliptin (Tradjenta).
"Health care professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control," said the agency on its website. "If a patient's blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required."
Both trials reviewed by the FDA showed that more patients taking saxagliptin and alogliptin were hospitalized for heart failure compared with patients who received placebo or an inactive treatment. The data from one trial showed that 3.5% of patients on saxagliptin were hospitalized for heart failure versus 2.8% of patients on placebo. Risk factors included a history of kidney problems or heart failure.
And in the alogliptin trial, 3.9% of patients on the drug were hospitalized for heart failure versus 3.3% in the placebo group.
The warning about heart failure also applies to several combination products containing saxagliptin and alogliptin, including:
- Kombiglyze XR (saxagliptin and metformin extended release)
- Kazano (alogliptin and metformin)
- Oseni (alogliptin and pioglitazone)
The FDA has previously warned that DPP-4 inhibitors are linked to joint pain. The agency asked that serious problems with this class of drugs be reported to them via their online MedWatch program.