Onglyza and Kombiglyze XR Side Effects Led To Heart Damage, Heart Failure: Lawsuit

Side effects of the saxagliptin-based diabetes drugs Onglyza and Kombiglyze XR allegedly left a Texas man with heart damage and heart failure, according to allegations raised in a recently filed product liability lawsuit brought against Bristol-Myers Squibb and AstraZeneca.

The complaint (PDF) was filed by Ruben Barrientes in the U.S. District Court for the Southern District of New York on August 6, indicating that the drug makers failed to adequately warn about the heart risks with Onglyza and Kombiglyze XR.

Barrientes indicates that he took the drugs, which both contain the active ingredient saxagliptin, between May 2014 and February 2017. Due to side effects of Onglyza and Kombiglyza, Barrientes maintains that he has suffered heart failure, congestive heart failure and cardiovascular injury.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol Myers Squibb, and introduced in 2009 for treatment of type 2 diabetes. Although it has been marketed as safe and effective, concerns have emerged in recent years about potential heart risks, resulting in a number of Onglyza lawsuits being filed by former users. Similar claims have also been filed over an extended release version of the medication, known as Kombilgyze XR, which combines saxagliptin with the older diabetes drug metformin.

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.

Despite that information, Barrientes indicates that the manufacturers released Onglyza anyway, knowing it was no better than drugs already on the market.

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

The lawsuit indicates that the manufacturers continued to promote the drugs as safe despite numerous warning signs of heart problems.

“In addition to Defendants refusing and failing to warn of the risks of heart failure, congestive heart failure, cardiac failure and death, Defendants’ Saxagliptin drugs lack any benefit sufficient to tolerate the risks posed by its use because other anti-diabetes drugs are available that do not carry the increased cardiac risks of Saxagliptin,” Barrientes’ lawsuit states. “Defendants, with knowledge of the true relationship between use of Saxagliptin and heart failure, congestive heart failure, cardiac failure, and death related to those events, promoted and continue to promote Saxagliptin as a safe and effective treatment for type 2 diabetes mellitus.”

Barrientes’ case will be consolidated with other Onglyza lawsuits 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.