A new warning from the FDA alerts physicians and patients to an Onglyza danger that could put diabetes patients at risk for heart failure

In the April 2016 warning, the FDA announced that saxagliptin – the generic name for Onglyza – and one other diabetes medication can increase the patient’s risk of heart failure.

The risk is apparently more pronounced in patients who already have heart disease or kidney disease.

With this announcement, the FDA added a new warning to the label for Onglyza, alerting patients and care providers to the increased risk of heart failure associated with Onglyza.

The FDA recommends patients at risk for Onglyza danger contact their treatment provider at once if they experience symptoms of heart failure such as more shortness of breath than usual during daily activities; difficulty breathing while lying down; weight gain simultaneous with swelling in the ankles, feet, legs or stomach; or feeling tired, weak or fatigued.

Onglyza is one of the newer medications used to treat type-2 diabetes. It’s one of a class of drugs called DPP-4 inhibitors.

As a group, DPP-4 inhibitors work by increasing the amount of insulin released into the blood after meals.

The extra insulin helps move blood sugar from the blood and into the surrounding tissues, helping reduce the high levels of blood sugar associated with type-2 diabetes.

The same active component of Onglyza is also present in the medication Kombiglyze XR, which combines saxagliptin with the older diabetes drug metformin. The FDA’s warning applies to Kombiglyze XR as well as to Onglyza.

Potential Onglyza Danger Revealed in Clinical Trial

The FDA issued this warning partly in response to the results of a clinical trial that showed a greater Onglyza danger for heart failure.

Patients in that trial who received Onglyza (referenced in the trial by its generic name saxagliptin) were hospitalized for heart failure at a rate of 3.5 percent, compared to a rate of 2.8 percent of patients who were given a placebo.

Patients in the trial who had a history of heart failure or kidney impairment were at a greater risk for heart failure, according to the FDA.

Based on the result of this trial, in April 2015 an FDA advisory committee recommended adding new warnings to the label for Onglyza.

Heart failure is a condition in which the heart fails to pump as much blood as it should. Generally, most patients do not have any symptoms at first. They may gradually develop shortness of breath and fatigue over several months.

Depending on the type of heart failure, it can result in an accumulation of fluid in the extremities or the torso, or within the lungs themselves. More advanced heart failure can lead to breathing abnormalities like obstructive sleep apnea or a condition known as Cheyne-Stokes breathing.

The FDA’s warning also alerts patients to other possible Onglyza danger. Other than heart failure, side effects of Onglyza may include inflammation of the pancreas (known as pancreatitis), severe joint pain (arthralgia), allergic reactions and low blood sugar when combined with other medications for diabetes.