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A North Carolina woman indicates that the side effects of Onglyza caused her to suffer heart failure, according to a lawsuit filed this month against the makers of the diabetes drug.
Bobbie Jean Singletary filed the complaint (PDF) in the U.S. District Court for the Eastern District of Kentucky on November 5. indicating that Bristol-Myers Squibb, AstraZeneca, and McKesson Corporation failed to adequately warn consumers and the medical community about the heart failure risk.
Singletary claims that she was prescribed Onglyza in May 2013, and continued to use the diabetes drug until May 2016. In February 25, 2014, she was diagnosed with heart failure.
AstraZeneca and Bristol Myers Squibb jointly developed Onglyza (saxagliptin), introducing the type 2 diabetes treatment in 2009. Although it has been marketed as safe and effective, concerns have emerged in recent years about potential risk of heart damage, resulting in a number of similar Onglyza lawsuits being filed by former users in courts nationwide.
The litigation emerged after the FDA launched an investigation into the heart risks with Onglyza in 2014, following the publication of a study, known as “SAVOR”, in the New England Journal of Medicine. However, the lawsuit filed by Barrientes claims that clinical trials showed that users had a significantly increased risk of being hospitalized for heart failure as far back as 2008, a year before Onglyza was introduced.
The lawsuit claims the manufacturers intentionally hid Onglyza’s health risks from the medical community and consumers.
“At all relevant times, 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,” Singletary’s lawsuit states. “These concerted efforts resulted in significant harm to those treated with Saxagliptin, including Plaintiff. But for the actions of Defendants, individually, jointly, and in concert with one another, Plaintiff would not have ingested Saxagliptin.”
In April 2016, the FDA felt there was enough proof of causation to issue Onglyza heart failure warnings. The risk information was also added to other drugs that belong to the same class of diabetes medications, known as dipeptidyl peptidase-4 (DPP-4) inhibitors, such as Kombiglyze XR, Nesina, Kazano and Oseni.
The warnings were issued after a review that 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.
Singletary’s case will be consolidated with other Onglyza cases pending in the federal court system, which were combined as part of a federal MDL, or multidistrict litigation, earlier this year for coordinated discovery and pretrial proceedings. The litigation is centralized before U.S. District Judge Karen K. Caldwell in the U.S. District Court for the Eastern District of Kentucky.