Onglyza Heart Failure Lawsuit Filed Over Failure to Warn

According to allegations raised in a product liability lawsuit filed against AstraZeneca and Bristol-Myers Squibb, side effects of Onglyza and Kombiglyze XR caused a Georgia woman to suffer hear failure and other injuries after taking the diabetes drugs. 

The complaint (PDF) was filed by Cynthia Turner in the U.S. District Court for the Northern District of Georgia on July 24, indicating that the drug makers failed to adequately warn about the heart failure risks associated with saxagliptin, which is the active ingredient in both Onglyza and an extended release version combined with metformin, which is marketed as Kombiglyze XR.

Turner indicates that she used the medications from about 2013 to 2014, claiming that Onglyza and Kombiglyze XR caused her to develop heart failure, congestive heart failure and other cardiovascular injuries.

Although there were no Onglyza heart failure warnings when Turner used the medication, the FDA required the drug makers to update the label information in April 2016, adding warnings to saxagliptin-based drugs, and other diabetes treatments that are part of a class known as dipeptidyl-peptidase-4 (DPP-4) inhibitors.

“At all relevant times, 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,” the lawsuit filed by Turner 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.”

The FDA 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.

Turner’s claim comes as a growing number of individuals nationwide are now pursuing Onglyza lawsuits, alleging that the drug makers failed to adequately warn users or the medical community about the heart failure risks.