Federal regulators have stated that AstraZeneca’s diabetes drug Onglyza should carry a label notifying users of the risks of heart failure, but added the risk is acceptable.

The warning was issued after the FDA completed a broader investigation into the safety of diabetes drugs. In December 2008, the agency issued guidance requiring companies to conduct studies to show that Onglyza and other diabetes medications did not increase cardiovascular risk.

The FDA regulators found that while Onglyza did not increased the risk of cardiovascular death, stroke, or heart attack, data showed a statistically significant increase in the risk of heart failure with Onglyza, and therefore merited a label warning. The panel did not recommend any restrictions on prescribing the diabetes drug.

What is Onglyza?

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 cardiovascular risks from Onglyza, including heart failure.

What is Heart Failure?

Heart failure is a condition in which the heart cannot pump enough blood to meet the body’s needs. According to the Mayo Clinic, it can be caused by coronary artery disease, high blood pressure, diabetes, or obesity.

When the heart muscle is too weak to pump enough blood into the body, cells are starved 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, fatigue, weakness, and swelling in the legs, ankles, or feet.

FDA Warns Onglyza Heart Failure Risk

The FDA’s report, posted on the agency’s website, stems from an April 14 meeting of an FDA advisory panel to discuss the safety of Onglyza.

A trial of more than 16,000 patients known as SAVOR previously showed patients taking Onglyza, also known as saxagliptin, had an increased risk of hospitalization due to heart failure.

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

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

FDA staff reviewers not only flagged a potential risk of heart failure, but staffers also identified an increase in the rate of “all-cause mortality” among the Onglyza patients in that trial. The FDA panel recommended that the diabetes drug’s label include information about a potential risk of heart failure.

Onglyza Lawsuits

Onglyza is a diabetes medication that has been linked to multiple alarming and potentially fatal side effects, including  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.