A Kentucky woman who developed heart failure after being prescribed Onglyza and Kombiglyze XR to treat her Type 2 diabetes has become one of the latest plaintiffs to take legal action against AstraZeneca and Bristol-Myers Squibb.
The plaintiff is being represented by the nationwide law firm of Bernstein Liebhard LLP. According to a complaint filed on her behalf late last month in the U.S. District Court, Southern District of New York, she was prescribed Saxagliptin – the active ingredient in Onglyza and Kombiglyze XR – from approximately April 2014 to August 2016. The woman subsequently developed heart failure, congestive heart failure, and cardiovascular injury, which she contends was a direct and proximate result of her treatment with Saxagliptin.
Her Onglyza lawsuit further alleges that Astra Zeneca and Bristol-Myers Squibb were aware that Saxagliptin was associated with a significant increased risk of heart failure, congestive heart failure, cardiac failure, and death, but continued to market Onglyza and Kombiglyze XR without appropriate safety warnings.
“On information and belief, Plaintiff’s prescribing physicians would not have prescribed Saxagliptin to Plaintiff, would have changed the way in which they treated Plaintiff’s relevant conditions, changed the way they warned Plaintiff about the signs and symptoms of serious adverse effects of Saxagliptin, and discussed with Plaintiff the true risks of heart failure, congestive heart failure, cardiac failure, and death related to those events, and other serious adverse events had Defendants provided said physicians with an appropriate and adequate warning regarding the risks associated with the use of Saxagliptin,” the complaint charges.
Saxagliptin belongs to a class of Type 2 diabetes medications called DPP-4 inhibitors. DPP-4 is an enzyme that breaks down GLP-1, an incretin hormone that stimulates the body to release insulin in response to a meal.
Onglyza, which contains only Saxagliptin, was approved by the U.S. Food & Drug Administration (FDA) in 2009. Kombiglyze, a combination of Saxagliptin and metformin, was approved in 2010.
In April 2016, the FDA ordered the manufacturers of all Saxagliptin-containing medications to add new heart failure warnings to their product labels, after interim results from a major clinical trial suggested that patients treated with the drugs were 27% more likely to be hospitalized with heart failure. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
Dozens of plaintiffs have since filed Onglyza and Kombiglyze XR lawsuits seeking compensation for cardiovascular injuries allegedly related to their use of Saxagliptin. Earlier this year, all such federal claims were centralized before a single judge in the U.S. District Court, Eastern District of Kentucky. Nearly 100 cases are currently pending in that proceeding