A recent Onglyza lawsuit claims that the diabetes medication can increase the risk of heart failure and other cardiac problems.

Saxagliptin, also sold under brand names Onglyza and Kombiglyze XR, is part of the drug class of DPP4 inhibitors. These drugs influence enzymes in the body which allow insulin to be produced for much longer after meals than what is natural without medication. Although this mechanism is effective at treating diabetes, it may lead to long term harm in patients.

Plaintiff Jerry B. allegedly took Onglyza from January 2018 to July 2018 for the treatment of his Type-2 diabetes. While using the drug, Jerry allegedly suffered from congestive heart failure which lead to a massive heart attack that required a quadruple bypass.

After suffering from his dramatic cardiac injuries, Jerry consulted with a lawyer to bring claims that Onglyza caused serious damages both short and long term.

“As a result of said injuries, Plaintiff suffered significant bodily and mental injuries, pain and suffering, mental anguish, disfigurement, embarrassment, inconvenience, loss of earnings and earning capacity and have and will incur past and future medical expenses,” the Onglyza heart failure lawsuit claims.

According to Jerry, Onglyza was not sufficiently tested before being released to the public. He claims that the “drastic alterations” the drug makes to the natural incretin cycle can cause an increased risk of cardiovascular events.

In 2008, the U.S. Food and Drug Administration (FDA) required all new diabetes medication applicants to show that their drugs do not cause cardiovascular risk increases. However, Jerry claims that Onglyza manufacturers failed to sufficiently test their products for cardiovascular risks before releasing the drug onto the market in 2009.

Eventually, the cardiovascular risks of Onglyza were reportedly revealed in an outcome trial referred to as SAVOR. The data from these trials allegedly showed that patients on Onglyza and Kombiglyze XR were at a higher risk for hospitalization due to heart failure.

Heart failure occurs whenever a heart loses the ability to pump blood. Heart failure is typically caused by narrowed arteries from coronary artery disease or high blood pressure, as these conditions can result in the heart muscles becoming weak or stiff.

Due to the results of the SAVOR trial, an FDA committee allegedly voted 14 to 1 to add new heart failure warnings to saxagliptin drug labels.

The only committee member who did not vote to add the warnings instead voted to completely withdraw the drug from the market, according to the Onglyza lawsuit. Despite these rulings, Onglyza manufacturers allegedly refuse to warn patients that of the severe cardiac risks associated with the diabetes medication.

“Defendants over-promoted Saxagliptin and under-warned about Saxagliptin’s risks through various avenues,” Jerry claims in his Onglyza cardiac failure lawsuit. “At no time did Defendants perform adequate safety testing on Saxagliptin prior to marketing their drugs to the American public and failed to do so until performing the SAVOR trial.”

The Onglyza heart lawsuit includes claims of design defect, negligence, failure to warn, breach of express warranty, breach of implied warranty, and violation of the Kentucky Consumer Protection Act. The case seeks compensatory damages, punitive damages, interest, court costs, and attorneys’ fees.

The Onglyza Lawsuit is Case No. 5:19-cv-00252-KKC in the U.S. District Court for the Eastern District of Kentucky.