Onglyza (saxagliptin) is a type-2 diabetes drug intended to help control blood sugar levels. However, a recent clinical trial concluded that use of Onglyza and heart failure may be linked.

Onglyza was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca.

It was approved by the FDA in July 2009, for treatment of type 2 diabetes and generated more than $700 million in sales in 2012.

Studies Differ on Onglyza and Heart Failure Risk

A recent clinical trial evaluated 16,492 type-2 diabetics to determine the safety and efficacy of Onglyza. The trial is known as the SAVOR Study.

The SAVOR study found that people taking Onglyza were 27 percent more likely to require hospitalization for heart failure compared to people who did not take Onglyza.

Dr. Benjamin Scirica, the SAVOR Principle Investigator, concluded that “though unexpected, the incremental risk of heart failure hospitalizations observed with saxagliptin is likely valid…”

However, two other studies raise doubts about Onglyza and heart failure.

In a study published in May in the medical journal JAMA Cardiology, as well as a study published in June in the Annals of Internal Medicine, researchers failed to find any association between use of Onglyza and heart failure risk.

The study published in the Annals of Internal Medicine was funded by the FDA, looking at data from 18 health insurance and health systems. It involved 78,553 Onglyza users and nearly 300,000 Januvia (another diabetes treatment drug) users from 2006 to 2013.

The other study was an analysis of a clinical trial known as the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), which involved data on 14,671 patients, about half of whom were given Januvia and half of whom were given a placebo.

Neither showed a statistically significant increase in hospitalization from heart failure or heart failure mortality. However, the studies contradict findings the SAVOR study.

FDA Issues Safety Alert for Onglyza and Heart Failure

Following the release of the SAVOR study, the FDA formed an Advisory Committee of 15 members to evaluate Onglyza.

On April 5, 2016, the FDA required AstraZeneca to change the Onglyza label to warn patients that taking the diabetes drugs may increase the risk of heart failure.

The FDA’s Safety Communication also advised doctors to consider stopping the use of Onglyza in patients who develop heart failure.

Filing an Onglyza Lawsuit

Reports indicate that AstraZeneca, the company that makes and sells Onglyza has known about the connection between Onglyza and heart failure since as early as 2013.

A growing number of individuals nationwide are now pursuing Onglyza lawsuits against AstraZeneca, alleging that consumers and the medical community were not provided adequate warnings about the potential heart failure risks.

To learn more about your legal rights, or the legal rights of a loved one, contact an experienced Onglyza attorney for a free and confidential consultation.