The widow of an Ohio man has filed a product liability lawsuit against Bristol-Myers Squibb and AstraZeneca, indicating that the side effects of Onglyza caused her husband to suffer congestive heart failure before his death.
Phyllis Marcum filed the complaint (PDF) in the U.S. District Court for the Southern District of Ohio on April 27, on behalf of herself and the estate of her late husband, Charles Marcum.
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 heart risks, leading the FDA to add new information about the heart risks to the drug label in 2016.
According to the case, Charles Marcum took Onglyza for treatment of diabetes from June 2012 to July 2016, which allegedly caused him to develop congestive heart failure in October 2015. His wife indicates that he continued to take the drug because the manufacturers failed to provide adequate warnings to patients or the medical community about potential Onglyza heart risks.
“A reasonable person who had actual knowledge of the increased risks associated with using the drugs would have concluded that Onglyza and Saxagliptin should not have been marketed to or used by Decedent and his physicians,” the lawsuit states. “Despite the fact Defendants knew or should have known of the defective nature of the drugs, Defendants continued to design, manufacture and sell Onglyza and Saxagliptin so as to maximize sales and profits at the expense of the public health and safety. Defendants thus acted with conscious and deliberate disregard of the foreseeable harm caused by Onglyza and Saxagliptin.”
Onglyza Heart Failure 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.
Marcum’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.
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