Onglyza (saxagliptin), a diabetes drug manufactured by AstraZeneca and Bristol-Meyers Squibb, is facing increasing scrutiny for allegedly causing heart failure.

AstraZeneca and Bristol Meyers Squibb have previously been warned by the Food and Drug Administration (FDA) to add stronger warnings about Onglyza’s potentially increased risk of heart failure.

This FDA warning comes after a review of clinical trials suggesting that those who use Onglyza to combat diabetes are at higher risk of heart failure hospitalization than others, as well as at a higher risk of mortality from all causes.

Risk of Onglyza Heart Failure

A study funded by Onglyza manufacturers, known to the medical community as the SAVOR study, evaluated 16,492 type-2 diabetes patients. The study found that patients who took Onglyza were hospitalized due to heart failure at a slightly higher rate than those who did not use Onglyza, and used other type-2 diabetes drugs instead.

Heart failure is a serious and potentially life-threatening medical condition in which the heart becomes so weak that it cannot adequately pump blood throughout the body. High blood pressure or coronary artery disease can eventually lead to heart failure by gradually weakening the heart.

Even if a patient survives heart failure, they are typically forced to make significant changes to their daily life. These kinds of permanent changes may include improving their diet, reducing their level of salt intake, exercising, losing weight, and/or managing stress more effectively. All of these things can reduce the risk of further complications.

The SAVOR study did find that patients who took Onglyza were hospitalized at a higher rate, but this increase was not considered to be statistically significant.

Nevertheless, some experts believe that this potential link between Onglyza and heart failure deserves further investigation.

Background of Onglyza

Onglyza was approved by the FDA in July 2009 for the treatment of type-2 diabetes. This diabetes drug is part of a class of drugs called incretin mimetics, which also include several similar, widely used drugs such as Januvia, Janumet, Byetta, Victoza, and others. These kinds of drugs work by mimicking the body’s natural incretin hormones, used to stimulate the release of insulin after a meal.

Many people allege that ingesting Onglyza directly led to major side effects, including Onglyza heart failure. Patients may consider filing Onglyza heart failure lawsuits against AstraZeneca and Bristol-Meyers Squibb, for failing to adequately warn and inform the medical community and consumers of potential heightened risk factors of their drug.

Studies have found other potentially serious and even life-threatening Onglyza side effects besides heart failure. Onglyza has also been connected to increased pancreatic and thyroid cancer risks.