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Bristol-Myers Squibb and AstraZeneca allegedly misled patients and the medical community about the heart risks with Onglyza, according to allegations raised in a product liability lawsuit filed this month by an Ohio man who indicates that the diabetes drug caused him to develop coronary artery disease and congestive heart failure.
The complaint (PDF) was filed by Victor Young in the U.S. District Court for the District of New Jersey, indicating that over the last several years he took Onglyza and Kombiglyze XR, which combines the active ingredient in Onglyza with metformin.
As a result of saxagliptin contained in the diabetes drugs, Young indicates that he has been left with serious and permanent heart injuries, maintaining that the drug makers intentionally withheld information about the potential side effects.
“At all relevant times, Defendants had knowledge that there was a significant increased risk of adverse events associated with Saxagliptin including heart failure, congestive heart failure, cardiac failure, and death related to those events, and despite this knowledge Defendants continued to manufacture, market, distribute, sell and profit from sales of Saxagliptin,” the lawsuit states. “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 using Saxagliptin including but not limited to heart failure, congestive heart failure, cardiac failure, and death related to those events.”
Although Onglyza and Kombiglyze XR have been marketed as a safe and effective diabetes drug, concerns have emerged in recent years about the potential heart risks, leading the FDA to add new information about the heart risks to the drug label in 2016. However, the complaint indicates that as far back as 2008, a year before Onglyza was approved, clinical trials showed that users of the drug had a statistically significant increased risk of being hospitalized for heart failure. The lawsuit claims that, despite that, the manufacturers released it anyway, knowing it was no better than drugs already on the market.
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.
Young’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 federal 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.