Onglyza Heart Failure Risk Prompts New FDA Warning

Published on April 7, 2016 by Sandy Liebhard

Patients who use Onglyza (saxagliptin) should be on guard for heart failure symptoms, according to a new warning from U.S. drug safety regulators. Labels for Onglyza and number of other Type 2 diabetes drugs are now being updated to provide patients and doctors with information about this risk.

The alert from the U.S. Food & Drug Administration (FDA) was issued on April 5th, nearly a year after an agency advisory committee recommended new heart failure warning for Type 2 diabetes drugs that contain saxagliptin or alogliptin. The FDA’s final decision followed a review of two large clinical trials involving patients with a history of heart disease who took the medications.

In addition to Onglyza, Type 2 diabetes drugs subject to the new warning and label modifications include:

  • Kombiglyze XR (saxagliptin and metformin extended release)
  • Nesina (alogliptin)
  • Kazano (alogliptin and metformin)
  • Oseni (alogliptin and pioglitazone)

All of the medications belong to a class called dipeptidyl peptidase-4 (DPP-4) inhibitors. However, the warning does not extend to two other medications in this category, Januvia (sitagliptin) and Tradjenta (linagliptin).

The two clinical trials reviewed by the FDA compared patients taking saxagliptin or alogliptin with others who were treated with a placebo. Results from one of the studies showed that 3.5% of patients on saxagliptin were hospitalized for heart failure versus 2.8% of patients on placebo. In the alogliptin trial, 3.9% of patients on the medication were hospitalized for heart failure versus 3.3% in the placebo group. Risk factors included a history of heart or kidney disease.

Heart Failure Symptoms

The FDA has advised that patients taking these medications contact their doctor right away if they experience:

  • Unusual shortness of breath during daily activities
  • Trouble breathing when lying down
  • Tiredness, weakness, or fatigue
  • Weight gain with swelling in the ankles, feet, legs, or stomach

Patients should not stop taking their medicine without first talking to their health care professionals.

“Health care professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control,” the FDA said. “If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.”


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