Bristol-Myers Squibb faces a lawsuit from a consumer alleging that the company conceal evidence linking Onglyza and congestive heart failure.

Plaintiff Georgia M. says she took Onglyza from June 2010 to August 2015. While taking the drug, in 2011, Georgia says she was diagnosed with congestive heart failure. She claims that her heart failure was a direct result of her treatment with Onglyza, a risk that Bristol-Myers Squibb allegedly concealed from consumers.

Onglyza (saxagliptin) is a type-2 diabetes medication which influences the insulin secretion process. The drug enables the stimulation of insulin after meals for longer than it would occur naturally. However, Georgia argues that this mechanism may increase the risk of cardiovascular side effects and Onglyza and congestive heart failure. 

In December 2008, the U.S. Food and Drug Administration (FDA) released guidance requiring applicants for type-2 diabetes medications to show that their medication does not increase the risk of cardiovascular problems. The FDA determined that, because diabetes patients are already at a higher risk for cardiovascular complications, the medications designed to treat the condition should not also increase these risks.

However, Bristol-Myers Squibb allegedly sold their drug for five years without testing the relationship between Onglyza and congestive heart failure. When they finally conducted trials, they allegedly showed that the drug was not as safe as they had believed.

The trial, dubbed the “SAVOR” trial, allegedly showed that there was a significant link between Onglyza and congestive heart failure, with saxagliptin users having a “statistically significant increased risk of being hospitalized due to heart failure”.

Congestive heart failure occurs when the heart becomes unable to pump blood effectively. This can occur due to a variety of reasons including coronary artery disease, high blood pressure, or other conditions which leave the blood vessels too weak or stiff to pump blood well enough.

The condition can be life threatening, and there is no cure. In some cases, the condition can be managed by treating the underlying cause. In other cases, the use of pacemakers and similar devices or surgical intervention may be required.

After reviewing the raw data from the SAVOR trial, the FDA panel allegedly voted 14 to 1 to recommend adding a heart failure warning to its products. The only opposing member of the vote allegedly stated that the warning was insufficient and that the drug should be removed from the market. In April 2016, the FDA announced the results of the research and ordered that new warnings be added to the label.

However, Georgia claims Bristol-Myer Squibb allegedly failed to comply with this order and has not warned consumers of the link between Onglyza and congestive heart failure.

“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,” the Onglyza lawsuit claims.

The Onglyza and Congestive Heart Failure Lawsuit is Case No. 5:18-cv-00648-KKC and is part of the Onglyza MDL, In re: Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) Products Liability Litigation, Case No. 5:18-md-2809-KKC. in the U.S. District Court for the Eastern District of Kentucky.