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According to allegations raised in a product liability lawsuit filed against Bristol-Myers Squibb and AstraZeneca, the pharmaceutical companies have concealed the potential Onglyza heart failure risks from consumers and the medical community, providing false and misleading information about the safety of their diabetes drug.
The complaint (PDF) was filed by Robert Curtis in the U.S. District Court for the Eastern District of Kentucky on April 4, indicating that he developed heart failure and other cardiovascular injuries after taking Onglyza and Kombiglyze XR, which combines the active ingredient in Onglyza with metformin.
Onglyza (saxagliptin) was jointly developed by AstraZeneca and Bristol Myers Squibb, and introduced in 2009 for treatment of type 2 diabetes. Although the medication has been marketed as a safe and effective diabetes drug, concerns have emerged in recent years about the potential side effects of Onglyza, leading the FDA to add new information about the heart risks to the drug label in 2016.
Curtis indicates that the drug markers know about the link between saxagliptin and heart failure, yet continued to market Onglyza and Kombiglyze XR as safe and effective.
“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 saxagliptin, including, but not limited to heart failure, congestive heart failure, cardiac failure and death related to those events,” according to the lawsuit, which indicates that Curtis’ physicians would not have prescribed Onglyza or Kombiglyze XR if the heart failure risks had been appropriately disclosed.
The lawsuit also maintains that Onglyza lacks sufficient benefit to justify the heart failure risks, since other diabetes drugs are available that are not associated with the same side effects.
Onglyza Heart Concerns
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.
Curtis’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.
Earlier this year, 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.