Onglyza and heart failure is a prominent concern in the medical community, as this popular type-2 diabetes medication is prescribed to many patients nationwide on a daily basis. The recent reports indicating a correlation between Onglyza and heart failure have physicians and diabetes patients more hesitant to start any medication regimen with this drug.

The potential association between Onglyza and heart failure was first seen in the SAVOR study, in the 2013 issue of the New England Journal of Medicine. This study analyzed the medical history of 16,492 type-2 diabetes patients, with a reasonable portion of them prescribed Onglyza.

Researchers found that patients prescribed Onglyza had a 27% increased risk of hospitalization due to heart failure, compared to the control group. After the SAVOR study was shared with the FDA, the federal agency issued a public safety warning regarding Onglyza and heart failure in April 2015.

The agency stated that Onglyza, and other saxagliptin drugs, were associated with significant frequency of hospitalization for heart failure with the highest risk in patients who are already suffering from heart or kidney disease.

The potential link between Onglyza and heart failure has initiated so much concern that at least one reviewer on the FDA panel had suggested the drug be completely removed from the United States market.

Even with the concern, the FDA panel had decided to leave the medication on the market. The panel had made this decision based on the fact that there was not enough evidence to confirm whether or not Onglyza and heart failure had a definitive link.

The panel noted that the potential Onglyza and heart failure injury reports had a lower than 30% submission rate, which means the FDA did not consider it statistically significant. The FDA did state that the panel did recommend that heart failure should be added to the Onglyza warning label.

Overview of Onglyza and Heart Failure Concern

Onglyza (saxagliptin) was approved by the FDA on July 21, 2009, and is a member of the incretin mimetic drug family. Incretin mimetics work by helping the body produce more insulin by signaling the pancreas, which helps regulate blood sugar levels and prevent severe diabetic symptoms.

Insulin is needed for the body’s metabolic processes, which includes the process of retrieving nutrients and energy from food. If the body does not have sufficient insulin, the body cannot metabolize sugar and instead metabolizes fat. This creates the build up of ketones, which can potentially lead to kidney failure and diabetic ketoacidosis.

Due to the nature of type-2 diabetes, patients can sometimes expect cardiac complications due to issues with blood sugar. Heart failure occurs due to the cardiac muscle is too weak to pump blood effectively, which can be made worse by high blood pressure.

At this point in time, medical experts are unsure how Onglyza may induce heart failure but are still warning patients and doctors to be aware of the medication side effects.

Patients who may have experienced injury due to the alleged link between Onglyza and heart failure may be able to file legal action against manufacturer, AstraZeneca.