Onglyza Lawsuit Filed Over Heart Failure Risks

According to allegations raised in a recent product liability lawsuit, Bristol-Myers Squibb and AstraZeneca failed to adequately warn consumers and the medical community about the risk of heart failure from side effects of Onglyza.

The complaint (PDF) was filed earlier this month by Wrendell Chester in the U.S. District Court for the Southern District of Texas, indicating that he suffered severe injuries after using Onglyza and Kombiglyze XR, which combines the active ingredient in Onglyza with the older diabetes drug metoformin.

Chester started to use the saxagliptin-based diabetes drugs in 2010, and stayed on them until 2015. As a result of Onglyza side effects, Chester indicates that he suffered heart failure, congestive heart failure and acute hypoxic respiratory failure, which the lawsuit says left him with significant injuries.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca. It was approved by the FDA in July 2009, for treatment of type 2 diabetes and generated more than $700 million in sales in 2012. Kombiglyze is a long-acting version that combines Onglyza and metformin, another front-line diabetes drug.

Although the medications have been marketed as safe and effective, Chester indicates that the drug makers withheld information about the heart failure risk with Onglyza.

The FDA launched a safety review into the Onglyza heart risks in February 2014, following publication of a study in the New England Journal of Medicine, known as “SAVOR”, which found an increased rate of hospitalization due to heart failure among Onglyza users compared to those given a placebo.

In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks, 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.

On April 5, 2016, the FDA issued a drug safety communication, announcing that new heart failure warnings will required for the diabetes drugs Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni, which are part of a class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors.

Chester’s lawsuit indicates that the manufacturers knew or should have known long before the drug hit the market, yet failed to conduct proper research and testing.

“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.”

The Onglyza lawsuit pursues claims against the drug makers for negligence, design defects, failure to warn and breach of warranties, seeking both compensatory and punitive damages.