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According to allegations raised in a product liability lawsuit recently filed against Bristol-Meyers Squibb and AstraZeneca, the drug makers have misled the public and medical community about the side effects of Onglyza and the risk of congestive heart failure linked to the diabetes drug.
In a complaint (PDF) filed in the U.S. District Court for the Northern District of Georgia on July 25, Wiley Williams, Jr. indicates that he developed congestive heart failure after taking Onglyza from November 2012 through May 2013.
Williams alleges that the drug makers withheld, concealed and downplayed information about the link between Onglyza and heart failure, misrepresenting that saxagliptin contained in the drug were as safe or safer than other diabetes treatments.
The lawsuit also names IPR Pharmaceuticals, Inc and McKesson Corporation, as additional defendants, and includes claims for loss of consortium presented by Williams’ wife, Rhudenia.
“Defendants acted in concert with one another in the Georgia to fraudulently convey false and misleading information concerning the safety Onglyza and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, and other adverse effects associated with Onglyza from the public, including Plaintiff Wiley Williams, his physicians, and other healthcare providers,” the lawsuit states. “These concerted efforts resulted in significant harm to those treated with Saxagliptin, including Plaintiff.”
Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol Myers Squibb, and introduced in 2009 for treatment of type 2 diabetes. Although it has been marketed as safe and effective, concerns have emerged in recent years about potential heart risks, resulting in a number of Onglyza lawsuits being filed by former users. Similar claims have also been filed over an extended release version of the medication, known as Kombilgyze XR, which combines saxagliptin with the older diabetes drug metformin.
The litigation emerged after the FDA launched an investigation into the heart risks with Onglyza in 2014, following the publication of a study, known as “SAVOR”, in the New England Journal of Medicine. However, the lawsuit filed by Williams claims that clinical trials showed that users had a significantly increased risk of being hospitalized for heart failure as far back as 2008, a year before Onglyza was introduced. Despite that information, Williams indicates that the manufacturers released Onglyza anyway, knowing it was no better than drugs already on the market.
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.
Williams’ case will be consolidated with other Onglyza lawsuits pending in the federal court system, which were combined as part of a federal MDL, or multidistrict litigation, earlier this year for coordinated discovery and pretrial proceedings. The litigation is centralized before U.S. District Judge Karen K. Caldwell in the U.S. District Court for the Eastern District of Kentucky.