Congestive Heart Failure And Cardiomyopathy Injuries Caused by Onglyza, Lawsuit Alleges

Bristol-Myers Squibb and AstraZeneca failed to adequately warn consumers and the medical community about the potential side effects of Onglyza, according to allegations raised in a product liability lawsuit filed by a man who suffered congestive heart failure and heart muscle problems after using the controversial diabetes drug. 

The complaint (PDF) was filed by Dennis Turner in the U.S. District Court for the Eastern District of Missouri on December 12, indicating that the drug makers withheld and concealed important safety information from consumers and the medical community, misrepresenting that Onglyza was as safe or safer than other available diabetes treatments.

Turner indicates that he was prescribed Onglyza from September 2012 to August 2015. However, while using the diabetes drug, he suffered congestive heart failure and a thickening of the heart muscles, known as cardiomyopathy, in October 2014.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol Myers Squibb, and introduced in 2009 for treatment of type 2 diabetes. However, the lawsuit claims there was no way for Turner or his doctor to know of the Onglyza heart risks because the company failed to provide adequate warning to patients or the medical community.

“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,” the 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.”

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

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.

Turner’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.