Lawsuit Alleges Onglyza and Kombiglyze XR Hid Health Risks

February 23, 2017 – A new lawsuit has been filed by Sanders Phillips Grossman in the U.S. District Court for the Southern District of Texas against Bristol-Myers Squibb Company, AstraZeneca-Pharmaceuticals and McKesson Corporation over the companies’ alleged failure to warn consumers and the medical community of the risk of heart failure for diabetes patients using Onglyza and Kombiglyze XR.

The plaintiff, Wrendell Chester used both Onglyza and Kombiglyze XR for approximately five years between 2010-2015 and suffered heart failure, congestive heart failure and acute hypoxic respiratory failure allegedly due to the two drugs.  He has been left with significant injuries.

Sanders Phillips Grossman took the case to the US District Court

“At no time during the development of its Saxagliptin drugs did Defendants perform adequate studies to determine if their drug, and its drastic alterations of the natural incretin hormone cycle, may cause increased risks of cardiovascular related adverse events,” the lawsuit states. “Such studies are essential when developing, and then marketing, diabetic drugs to individuals already at an increased cardiovascular risk.”

Onglyza was approved for use by the FDA in July 2009 for the treatment of type-two diabetes.  Kombiglyze XR is a longer acting version which combines Onglyza with metoformin, an older diabetes drug.  In 2012, Onglyza generated more than $700 million in sales.

In February 2014, the FDA performed a safety review into heart risks after the New England Journal of Medicine published a study that found increased hospitalizations for heart failure in patients who had taken Onglyza vs. those who had been given a placebo.

FDA warned of risks of heart failure

In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended by a vote of 14-1 for stronger warnings of Onglyza’s heart failure risks after reviewing clinical data that suggested patients may have a higher risk of hospitalization for heart failure as well.

The FDA issued a drug safety communication on April 5, 2016 which required heart failure warnings for Onglyza and Kombiglyze XR, as well as other diabetes drugs Nesina, Kozano and Oseni, all medications within a class called dipeptidyl peptidase-4 (DPP-4) inhibitors.

The lawsuit alleges negligence, failure to warn and breach of warranties.

Case No. 4:17-cv-00316, Texas Southern District Court