Onglyza Resulted in Heart Failure Diagnosis, Lawsuit Alleges

Following more than two years of treatment wit Onglyza and Kombiglyze XR, a lawsuit filed by the family of an Ohio man indicate that side effects of the diabetes drug resulted in a heart failure diagnosis.

The complaint (PDF) was filed late last month in the U.S. District Court for the Southern District of Ohio by Diana Lawrence, on behalf of herself and as personal representative for Thomas Lawrence, who allegedly developed heart failure, congestive heart failure and cardiovascular injury due to side effects of Onglyza and Kombiglyze XR.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol Myers Squibb, and introduced in 2009 for treatment of type 2 diabetes. Kombilgyze XR is an extended release version of the medication, which combines saxagliptin with the older diabetes drug metformin.

Although the drugs have been marketed as safe and effective, concerns have emerged in recent years about Onglyza heart failure risks, resulting in stronger warnings being required by the FDA last year.

Thomas Lawrence was prescribed Onglyza and Kombiglyze XR at various times from July 2012 through October 2014, for the treatment of diabetes. The lawsuit alleges that AstraZeneca and Bristol Myers Squibb provided false and misleading information about the safety of saxagliptin contained in the medications, failing to adequately warn consumers and the medical community about the risk of a heart failure diagnosis.

An investigation into the potential heart risks with Onglyza was first launched by the FDA in 2014, following the publication of a study, known as “SAVOR”, in the New England Journal of Medicine in 2013.

“At no time did Defendants perform adequate safety testing on Saxagliptin prior to marketing their drugs to the American public and failed to do so until performing the SAVOR trial,” the lawsuit notes. “Despite the findings of the SAVOR trial, Defendants still have not undertaken efforts to change the labels and reference materials for Saxagliptin to include a reference or warning regarding heart failure, congestive heart failure, cardiac failure, and death related to those events.”

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.

Lawrence’s claim joins a growing number of similar Onglyza lawsuits filed by individuals nationwide who say they developed heart failure or other health problems due to the lack of adequate warnings on the diabetes drug.

On February 2, the U.S. Judicial Panel on Multidistrict Litigation consolidated all Onglyza cases in the U.S. District Court for the Eastern District of Kentucky, as part of a federal MDL, or multidistrict litigation, where they will undergo coordinated pretrial proceedings under District Judge Karen K. Caldwell.