A plaintiff from Georgia has filed a new Onglyza lawsuit that accuses AstraZeneca of concealing the potential for heart failure and other side effects allegedly associated with saxagliptin, the active ingredient in the Type 2 diabetes medication.
According to a complaint filed in the U.S. District Court, Northern District of Georgia on July 25th, Wiley Williams Jr. used Onglyza from November 2012 through May 2013 to treat his diabetes.
He subsequently suffered serious and permanent side effects, including congestive heart failure on June 4, 2013. Williams alleges that these injuries were the direct and proximate result of his treatment with Onglyza.
“At all relevant times, Defendants acted in concert with one another in the Georgia to fraudulently convey false and misleading information concerning the safety Onglyza and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, and other adverse effects associated with Onglyza from the public, including Plaintiff Wiley Williams, his physicians, and other healthcare providers,” the complaint charges.
“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,” it continues. (Case No. Case 3:18-cv-00082-TCB)
Onglyza was approved by the U.S. Food & Drug Administration (FDA) in 2009 to lower blood sugar levels in people with Type 2 diabetes. A related drug called Kombiglyze XR, which contains both saxagliptin and metformin, came to market the following year.
Heart failure warnings were added to the labels for all saxagliptin-containing medications in April 2016, after early results from the SAVOR-TMI study suggested that patients treated with the drug were 27% more likely to be hospitalized with heart failure. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
Hundreds of plaintiffs are now pursuing heart failure lawsuits that accuse the manufacturers of Onglyza and Kombiglyze XR of failing to warn doctors and patients that saxagliptin may increase a patient’s risk for heart failure and other potentially life-threatening cardiovascular side effects. They further claim that they would never have used saxagliptin had proper warnings been provided.
Earlier this year, the U.S. Judicial panel on Multidistrict Litigation centralized all federally-filed saxagliptin heart failure lawsuits before a single judge in the U.S. District Court, Eastern District of Kentucky. The cases included in that litigation are undergoing coordinated discovery and other pre-trial proceedings in the interest of judicial efficiency and to preserve the resources of the courts, parties, and witnesses involved in the litigation.