Heart Failure Lawsuit Filed Over Onglyza, Kombiglyze XR Side Effects

Following the use of Onglyza and the combination drug Kombiglyze XR, an Oklahoma man indicates that he developed heart failure, according to allegations raised in a lawsuit filed this month against Bristol-Myers Squibb, AstraZeneca and McKesson Corporation.  

The complaint (PDF) was filed by Carl Hulbert in the U.S. District Court for the Eastern District of Oklahoma on September 1, indicating that the drug makers failed to adequately warn about the potential side effects of saxagliptin, the active ingredient contained in both Onglyza and Kombbiglyze XR.

Hulbert was prescribed Onglya and Kombiglyze XR on various occasions before developing heart failure, congestive heart failure, and cardiovascular injury, according to the lawsuit, which indicates that his doctors would have prescribed a different drug if proper safety information had been provided to consumers and the medical community.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol Myers Squibb, introduced in 2009 for treatment of type 2 diabetes. Kombiglyze XR is a long-acting version of Onglyza combined with metformin, another front-line diabetes drug.

Although the medications have been marketed as safe and effective, concerns have emerged in recent years about the heart failure side effects of Onglyza and Kombiglyze XR, resulting in stronger warnings being required by the FDA last year.

“Plaintiff’s prescribing health care providers were unaware of the true degree, incidence, and risk of heart failure, congestive heart failure, cardiac failure, and death related to those events associated with the use of Saxagliptin, and, if they had been informed, would have used and prescribed alternative therapies to Plaintiff,” Hulbert’s lawsuit states. “Defendants’ conduct was committed with knowing, reckless, conscious, wanton, willful and deliberate disregard for the value of human life and the rights and safety of consumers, including Plaintiff, thereby entitling Plaintiff to punitive and exemplary damages so as to punish and deter similar conduct in the future.”

The FDA first launched an investigation into the potential heart risks with Onglyza 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 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.

The FDA now recommends that health care professionals should consider a different medication if an individual develops heart failure on Onglyza or Kombiglyze XR.

Hulbert’s claim joins a growing number of 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.