Lawsuit Links Onglyza to Serious, Permanent Heart Injuries

Published on June 14, 2018 by Sandy Liebhard

A New Jersey man who allegedly developed serious and permanent cardiovascular injuries due to his use of Onglyza has joined the growing litigation involving the Type 2 diabetes drug.

Saxagliptin Allegedly Caused Coronary Artery Disease, Congestive Heart Failure

According to a complaint filed in the U.S. District Court, District of New Jersey, on May 15, Victor Young was treated with Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) for several years.

His Onglyza lawsuit alleges that Young’s exposure to saxagliptin resulted in serious and/or permanent adverse effects including, but not limited to, coronary artery disease and congestive heart failure.

“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 complaint 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,” it continues.

Young is seeking damages for Design Defect, Negligence, Failure to Warn, and Breach of Warranty. (Case No 3:18-cv-09273)

Onglyza and Heart Failure

Onglyza was approved by the U.S. Food & Drug Administration (FDA) in 2009. Kombiglyze XR came to market the following year.

In April 2016, the labels for Onglyza and Kombiglyze were updated with new heart failure warnings, after interim results from a major clinical trial called SAVOR-TMI suggested that patients treated with saxagliptin were 27% more likely to be hospitalized with heart failure. The medication also appeared to be associated with a higher risk of all-cause mortality.

Dozens of plaintiffs have since filed Kombiglyze and Onglyza lawsuits seeking compensation for heart failure and cardiovascular injuries allegedly related to the use of the Type 2 diabetes treatments. Like the Young complaint, they claim that the drugs’ manufacturers failed to warn patients that saxagliptin was associated with an increased risk of heart failure and other potentially life-threatening heart side effects.

Nearly 100 Onglyza and Kombiglyze lawsuits have since been filed in federal courts throughout the United States. Earlier this year, those claims consolidated before a single judge in the U.S. District Court, Eastern District of Kentucky for the purpose of coordinated discovery and other pre-trial proceedings.