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A product liability lawsuit alleges that the side effects of Onglyza and Kombiglyze XR caused an Illinois man to develop congestive heart failure.
Jerald Adams filed a complaint (PDF) in the U.S. District Court for the Central District of Illinois on January 9, indicating that Bristol-Myers Squibb, AstraZeneca and McKesson Corporation failed to adequately warn consumers and the medical community about the potential heart risks associated with their diabetes drug.
According to the lawsuit, Adams took Onglyza and Kombiglyze XR from April 2015 through December 2015, indicating that the active ingredient contained in the medications, saxagliptin, caused him to suffer congestive heart failure and cardiovascular injury.
Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol Myers Squibb, and introduced in 2009 for treatment of type 2 diabetes. Kombilgyze XR is an extended release version of the medication, which combines saxagliptin with the older diabetes drug metformin.
Although the medications have been marketed as safe and effective, concerns have emerged in recent years about the Onglyza heart risks, resulting in stronger warnings being required by the FDA last year.
An investigation into the potential heart risks with Onglyza was first launched by the FDA 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 side effects, 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.
“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,” Adams’ 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.”
The FDA now recommends that health care professionals should consider a different medication if an individual develops heart failure on Onglyza.
Adams’ 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.
Later this month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments over a request by a group of plaintiffs to consolidate all Onglyza litigation before one judge for pretrial proceedings. Plaintiffs note that there are currently more than 40 such lawsuits filed in federal courts nationwide, and say centralizing the cases would prevent duplicative discovery, avoid contradictory rulings, and serve the convenience of the courts, parties and witnesses.