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Less than a year after a Pennsylvania woman began using the diabetes treatment Onglyza, side effects resulted in the development of heart failure, according to allegations raised in a product liability lawsuit filed recently against the drug manufacturer.
Sharon McCay filed the complaint (PDF) on behalf of Viola Chapman on February 2, in the U.S. District Court for the Western District of Pennsylvania, naming Bristol-Myers Squibb, AstraZeneca and McKesson Corporation as the defendants.
According to the lawsuit, Chapman was prescribed Onglyza, and the combination treatment Kombiglyze XR, starting in February 2015. McCay indicates Chapman used the diabetes treatment until December 2015, alleging that while she was still on the drugs, Chapman suffered heart failure, 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 failure 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.
“In addition to Defendants refusing and failing to warn of the risks of heart failure, congestive heart failure, cardiac failure and death, Defendants’ Saxagliptin drugs lack any benefit sufficient to tolerate the risks posed by its use because other anti-diabetes drugs are available that do not carry the increased cardiac risks of Saxagliptin,” the lawsuit states. “Defendants, with knowledge of the true relationship between use of Saxagliptin and heart failure, congestive heart failure, cardiac failure, and death related to those events, promoted and continue to promote Saxagliptin as a safe and effective treatment for type 2 diabetes mellitus.”
McCay’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.
On February 2, 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.