AstraZeneca’s diabetes drug Onglyza may be associated with an increased rate of heart failure and death, according to a preliminary review of data by the U.S. Food and Drug Administration.

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-terms safety studies. Clinical trials have already found potential Onglyza heart failure risks.

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.

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 shortness of breath (dyspnea), fatigue, weakness, and swelling in the legs, ankles, or feet.

FDA Suggests Onglyza Heart Failure Risk

The FDA’s report, posted on the agency’s website, stems from an April 14 FDA advisory panel meeting to discuss Onglyza’s safety. Federal regulators discussed results from a clinical trial of more than 16,000 patients known as SAVOR, which showed patients taking Onglyza had an increased risk of hospitalization due to heart failure.

The agency’s analysis found the heart failure risk to be valid, and also identified a possible increased risk of death from all causes among patients taking Onglyza.

In December 2008, the FDA began requiring drug companies to conduct studies to show that new diabetes medications do not increase heart failure risks. The FDA guidance was developed amid growing concern about the safety of many diabetes medications.

AstraZeneca said the SAVOR study met the objective of showing that patients taking Onglyza were not at greater risk for heart failure, as measured by a composite benchmark comprising cardiovascular death, non-fatal heart attack, and non-fatal ischemic stroke.

Upon review, FDA staff flagged a potential risk of heart failure, which had already been publicly discussed, as well as an increase in the rate of “all-cause mortality” among the Onglyza patients in the SAVOR trial. The FDA panel recommended that the diabetes drug’s label include information about the potential risk of heart failure.

Onglyza Heart Failure Lawsuits

The diabetes medication Onglyza has been linked to multiple alarming and potentially fatal side effects, including pancreatic cancer, thyroid cancer, and heart failure.

If you or someone you love has suffered injury or death after taking Onglyza, you could be entitled to substantial financial compensation for medical bills and other damages.