Kombiglyze XR Heart Problems Concealed and Withheld by Drug Makers, Lawsuit Alleges

In a product liability lawsuit filed last week over the side effects of Kombiglyze XR, a North Carolina woman indicates that the combination diabetes drug caused her to develop heart failure, indicating that the drug makers knew about the risk of heart problems, yet withheld information from consumers and the medical community.

The complaint (PDF) was filed by Teresa Ann Freeman in the U.S. District Court for the Middle District of North Carolina on January 23, naming Bristol-Myers Squibb, AstraZeneca Corporation, and McKesson Corporation as defendants.

Freeman was prescribed Kombiglyze XR in November 2013, and continued to take the diabetes drug until October 2014, on the advice of her physician. The lawsuit indicates that on February 3, 2015, she began experiencing significant shortness of breath, and had difficulty breathing for several weeks until she was admitted to an emergency room. She was eventually diagnosed with acute left-sided systolic congestive heart failure.

Kombiglyze XR is an extended release combination of Onglyza (saxagliptin) and the older diabetes drug metformin. Although the new-generation diabetes treatments have been marketed as safe and effective, concerns have emerged in recent years about Onglyza and Kombiglyze XR heart risks, resulting in the FDA requiring stronger warnings on the drugs last year.

An investigation into the potential heart risks with saxagliptin contained in both medications was first launched by the FDA in 2014, following the publication of the SAVOR study by the New England Journal of Medicine in 2013.

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

Despite those previous findings, the lawsuit indicates that the manufacturers concealed and withheld information about the Kombiglyze XR heart failure risks until ordered to do so by the FDA years later.

“Defendants acted in concert with one another to fraudulently convey false and misleading information concerning the safety and efficacy of Kombiglyze XR and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure and other adverse effects associated with Kombiglyze XR from the public, Plaintiff, physicians, and other healthcare providers,” Freeman’s lawsuit states. “These concerted efforts resulted in significant harm to those treated with Kombiglyze XR, including Plaintiff.”

Freeman’s claim joins a growing number of similar Kombiglyz XR and 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.

Last week, the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments over a request by a group of plaintiffs to consolidate all Onglyza litigation before one judge for pretrial proceedings. Plaintiffs note that there are currently more than 40 such lawsuits filed in federal courts nationwide, and say centralizing the cases would prevent duplicative discovery, avoid contradictory rulings, and serve the convenience of the courts, parties and witnesses.