Onglyza heart failure risk was unwarned, according to a recent consumer lawsuit filed in federal court as part of a multidistrict litigation against drug manufacturers.

Plaintiff Lisa B. recently filed a lawsuit against Bristol-Myers Squibb, AstraZenca, and McKesson. Lisa argues that the drug manufacturers were aware of the increased Onglyza heart failure risk associated with the drug, but chose not to warn consumers.

Onglyza is a medication commonly prescribed for the treatment of type-2 diabetes. The drug works by enabling the stimulation of insulin longer than what occurs naturally after meals. This effect helps to treat type-2 diabetes by managing blood glucose levels.

Lisa says she was prescribed Onglyza in February 2016 and took the drug through April 2018. In October 2016, Lisa was diagnosed with heart failure, which she alleges was a direct result of her treatment with Onglyza.

In 2008, the U.S. Food and Drug Administration (FDA) released new guidance for diabetic drugs. The guidance noted that new diabetes treatments needed to demonstrate that the therapies would not increase the risk of cardiovascular injury. Because diabetes patients are already at an increased cardiovascular risk, the FDA determined that it was particularly important that diabetes medications don’t increase the already high risk.

Despite this guidance, Onglyza manufacturers allegedly waited until after they had marketed the drug and made significant profits to conduct Onglyza heart failure risk trails.

The companies eventually conducted the “SAVOR” trials, which reportedly concluded that there was a significant increase in Onglyza heart failure risk. The shocking results of the trials prompted an independent review of the data by the FDA.

The panel which reviewed the results of the trial allegedly voted 14 to 1 to add new Onglyza heart failure risk warnings to the drug’s packaging. The one member who voted against the warning allegedly felt that the warning was insufficient and that the drug should instead be taken off of the market completely. The panel recommended that new information should be added to the drug’s labeling.

In April 2016, the FDA issued a communication regarding the Onglyza heart failure risk. However, the manufacturing companies allegedly chose not to warn consumers of the increased Onglyza heart failure risk.

“Despite the SAVOR findings and despite the FDA Advisory Committee voting to add a warning (or remove the drugs from the market), Defendants failed and continue to fail to warn,” the Onglyza heart failure risk lawsuit claims. “Once again, Defendants place sales over patient safety.”

This lack of warning allegedly induced Lisa and her doctor to believe that Onglyza was a safe medication. Because they were unwarned, they allegedly were unable to make an informed treatment decision which led to Lisa developing heart failure.

Lisa brings claims of design defect, negligence, failure to warn, breach of warranties, and violation of Pennsylvania consumer protection laws. The Onglyza heart failure risk lawsuit seeks punitive damages, compensatory damages, court costs, and attorneys’ fees.

The Onglyza Heart Failure Risk Lawsuit is Case No. 5:18-cv-00562-KKC and is part of the Onglyza MDL, In re: Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) Products Liability Litigation, Case No. 5:18-md-2809-KKC, in the U.S. District Court for the Eastern District of Kentucky.