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Side effects of saxagliptin, which is contained in the diabetes drugs Onglyza and Kombiglyze XR, allegedly caused a Nevada man’s wrongful death due to heart failure, according to a recently filed lawsuit.
The complaint (PDF) was brought by Elke Mounteer in the U.S. District Court for the District of New Jersey on September 14, indicating that the drug makers failed to adequately warn about the risk of heart failure from Onglyza, which resulted in the death of her husband, Peter Otrebski.
According to the wrongful death lawsuit, Otrebski was prescribed Onglyza and Kombiglyze XR at various times between 2015 and 2017. The side effects of the drugs ultimately resulted in coronary artery disease, congestive heart failure, and death, which the complaint indicates are known risks that Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals should have warned consumers and the medical community about.
“At all relevant times, Defendants acted in concert with one another to fraudulently convey false and misleading information concerning the safety and efficacy of Saxagliptin and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure and other adverse effects associated with Saxagliptin from the public, Decedent, Decedent’s physicians, and other healthcare providers,” the lawsuit states.
AstraZeneca and Bristol Myers Squibb jointly developed Onglyza, introducing the type 2 diabetes treatment in 2009. Kombilgyze XR is a combination treatment that contains saxagliptin from Onglyza together with the older diabetes drug metformin.
Although it has been marketed as safe and effective, concerns have emerged in recent years about potential risk of heart damage, resulting in a number of similar Onglyza lawsuits being filed by former users in courts nationwide.
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 Barrientes 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.
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.
Mounteer’s case will be consolidated with other Onglyza cases 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.