Lawsuit Alleges Onglyza, Kombiglyze XR, Caused Heart Failure and Cardiovascular Injury

According to allegations raised in a product liability filed against Bristol-Myers Squibb and AstraZeneca, side effects of the saxagliptin-based diabetes drugs, Onglyza and Kombiglyze XR, caused a woman to suffer heart failure and other severe cardiovascular complications. 

In a complaint (PDF) filed in the U.S. District Court for the Northern District of Alabama on December 4, plaintiff Angela Hardy indicates that Onglyza and Kombiglyze XR are unreasonably dangerous drugs due to heart risks.

According to the complaint, Hardy took the drugs from 2014 to 2016, for the treatment of type 2 diabetes. However, she indicates that the side effects of Onglyza caused her to suffer heart failure, congestive heart failure, and other cardiovascular injuries.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol Myers Squibb, and introduced in 2009 for treatment of type 2 diabetes. Kombiglyze XR is a long-acting version of Onglyza combined with metformin, another front-line diabetes drug.

Although the medications have been marketed as safe and effective, concerns have emerged in recent years about the heart risks Onglyza and Kombiglyze XR, resulting in stronger warnings being required by the FDA last year.

The FDA first launched an investigation into the potential heart risks with Onglyza in 2014, following the publication of the SAVOR study by the New England Journal of Medicine in 2013.

In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality.

The review looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.

The FDA now recommends that health care professionals should consider a different medication if an individual develops heart failure on Onglyza or Kombiglyze XR.

“Defendants had knowledge that there was a significant increased risk of adverse events associated with Saxagliptin including heart failure, congestive heart failure, cardiac failure, and death related to those events, and despite this knowledge Defendants continued to manufacture, market, distribute, sell, and profit from sales of Saxagliptin,” Hardy’s lawsuit states. “Despite such knowledge, Defendants knowingly, purposely, and deliberately failed to adequately warn Plaintiff, patients, consumers, medical providers, and the public of the increased risk of serious injury associated with using Saxagliptin, including, but not limited to, heart failure, congestive heart failure, cardiac failure, and death related to those events.”

Hardy’s claim joins a growing number of similar Onglyza lawsuits filed by individuals nationwide who say they developed heart failure or other health problems due to the lack of adequate warnings on the diabetes drug.