Type-2 diabetes drug Onglyza is facing scrutiny by the FDA over the risk of heart failure and other side effects.

Onglyza (saxagliptin) belongs to a new class of diabetes medications that work by inhibiting the enzyme dipeptidyl peptidase-4.

Although this is a good way of improving blood sugar and insulin levels, many experts are concerned about a lack of long-term safety studies. Clinical trials have already found potential Onglyza heart failure risks.

The FDA is investigating harmful effects caused by Onglyza and other new diabetes medications regarding an increased risk of heart failure.  One of the FDA’s panel members advised that the drug should be withdrawn from the U.S. market but the safety panel instead opted to recommend a warning be added to prescribing information.

An FDA panel voted in April to require manufacturer AstraZeneca to place a warning on Onglyza labeling which would caution patients of a possible increased risk of heart failure.

This decision came after reviewing the data from the SAVOR study, which involved 16,492 patients, 1,222 of whom reported a major cardiovascular event.

In this study, AstraZeneca was required to show that Onglyza would not increase the risk of heart failure or other cardiovascular conditions by more than 30 percent. It was found that those patients taking Onglyza were found to have a 27 percent greater risk of hospitalization for heart failure than those in the control group.

Despite the manufacturer meeting the required threshold, the FDA panelists noted that more information was necessary in order to determine the actual risk of death from all causes associated with Onglyza. Indeed, 14 of the 15 panelists voted in favor of placing a warning on Onglyza labeling, while one panel member voted to withdraw the diabetes medication from the United States market altogether.

Symptoms of Heart Failure

Heart failure occurs when the heart muscle is too weak to pump enough blood into the body. This starves cells of the oxygen and nutrients they need to survive. Heart failure is a chronic, progressive condition that gets worse as the heart muscle thickens, loses flexibility, pumps faster, and ultimately grows weaker.

There is no cure for heart failure, but many people live for months or even years with symptoms. In most cases, people with heart failure get tired very easily and have shortness of breath. This can make daily activities extremely difficult — especially climbing stairs, carrying groceries, or walking.

Signs and symptoms of Onglyza heart failure may include:

• Difficulty breathing
• Swelling of hands, feet or ankles
• Irregular heart rate
• Fatigue
• Persistent cough or wheezing

Onglyza Heart Failure Lawsuits

Diabetes medications such as Onglyza are designed to improve the lives of patients who use them, but in some cases, the medications end up causing more harm than good.  If you or a loved one has suffered heart failure or other injuries after taking Onglyza, you may be eligible for compensation by filing a lawsuit.