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As a result of the failure to warn consumers and the medical community about the heart risks with Onglyza and Kombiglyze XR, a Kentucky woman indicates that she suffered heart failure, congestive heart failure and cardiovascular injury, joining a growing number of lawsuits filed against the drug manufacturers.
Cathy Nelson filed the complaint (PDF) in the U.S. District Court for the Southern District of New York on March 26, naming Bristol-Myers Squibb, Astrazeneca, and McKesson Corporation as defendants.
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 drugs have been marketed as safe and effective, concerns have emerged in recent years about Onglyza heart failure risks, resulting in stronger warnings being required by the FDA last year.
According to the lawsuit, Nelson took Onglyza and Kombiglyze XR from about April 2014 to August 2016, when she was diagnosed with a wide range of heart problems. The lawsuit indicates that neither she nor her doctor were adequately informed about the risk of heart failure linked to Onglyza use, because the manufacturers purposefully deceived patients and the medical community.
“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, Plaintiff, physicians, and other healthcare providers,” Nelson’s lawsuit states. “These concerted efforts resulted in significant harm to those treated with Saxagliptin, including Plaintiff.”
An investigation into the potential heart risks with Onglyza was first launched by the FDA in 2014, following the publication of a study, known as “SAVOR”, in 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.
Nelson’s 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.
Last month, the U.S. Judicial Panel on Multidistrict Litigation consolidated all Onglyza cases in the U.S. District Court for the Eastern District of Kentucky, as part of a federal MDL, or multidistrict litigation, where they will undergo coordinated pretrial proceedings under District Judge Karen K. Caldwell.