The FDA is investigating a link between Onglyza (saxagliptin) and heart failure. The agency launched the investigation after a study identified a 27 percent increased risk of heart failure among type-2 diabetics treated with the drug.

What is Heart Failure?

Heart failure, or “congestive 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. Signs and symptoms of Onglyza heart failure may include shortness of breath (dyspnea), fatigue, weakness, and swelling in the legs, ankles, or feet.

Onglyza Heart Failure

Onglyza 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-terms safety studies. Clinical trials have already found potential cardiovascular risks from Onglyza, including heart failure.

FDA Investigates Link for Onglyza and Heart Failure

Onglyza was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca. The medication is part of a class of drugs known as incretin mimetics, which also includes Januvia, Janumet, Byetta, Victoza and other widely used diabetes medications. It was approved by the FDA in July 2009 for treatment of type-2 diabetes. However, only drugs with the active ingredient saxagliptin are being reviewed.

At issue is data collected from a clinical trial known as SAVOR, which involved 16,492 subjects with type-2 diabetes, some of whom were given Onglyza and some of whom were given a placebo.

Study Links Increased Risk of Heart Failure and Onglyza

The study at issue was published in October 2013 in the New England Journal of Medicine. It linked Onglyza with a 27 percent increased risk of hospitalization for heart failure. The study did not indicate an increased risk of heart attack, stroke, or death. All of the patients had a history of heart disease or had other risk factors. Researchers tracked patients for a median of 2.1 years, and found that 3.5 percent of Onglyza patients were hospitalized for heart failure versus 2.8 percent of placebo patients.

In a new Safety Alert, the FDA has announced that they have requested raw data from the SAVOR-TIMI 53 clinical trial, the study linking Onglyza and heart failure. The FDA considers results of the SAVOR trial preliminary. They are currently investigating the heart risks of all type-2 diabetes drugs.

Onglyza Lawsuits

Onglyza is a diabetes medication that has been linked to multiple alarming and potentially fatal side effects, including pancreatic cancer, thyroid cancer, and even heart failure. If you or someone you love has suffered injury or death after taking Onglyza or a similar diabetes medication, you could be entitled to substantial financial compensation for medical bills and other damages.