A diabetes patient claims she wasn’t given a proper warning about the risk of saxagliptin heart failure.

In her recent saxagliptin lawsuit, plaintiff Shirley N. claims that she suffered injury as a result of her use of Onglyza and Kombiglyze XR, brand-name drugs that use the diabetes medication saxagliptin. She claims that she developed saxagliptin heart failure and other conditions as a result of taking the drugs.

Shirley claims that the drugs’ manufacturers, Bristol-Myers Squibb Company, AstraZeneca Pharmaceuticals, LP, and McKesson Corporation knew that the drug had the potential to cause patients heart problems, and nonetheless marketed and sold the drug, endangering the health of patients like Shirley.

The saxagliptin heart failure lawsuit states that sxagliptin is prescribed to lower blood sugar levels in people with type-2 diabetes. The lawsuit states that the drug induces glucose-dependent stimulation of insulin production while suppressing glucagon secretion. This, in turn, helps the diabetic person lower their blood sugar.

The saxagliptin heart failure lawsuit goes on to note that the synthetic nature prevents natural enzymes in the body from stopping the production of insulin at the point at which a body naturally would. This means that when a person uses the drug, their body products more insulin, and produces it for a much longer period of time, after eating a meal than a non-diabetic person’s body normally would.

Shirley claims the drugs’ manufacturers knew or should have known that the drug posed a serious risk to users’ cardiac health, and that they were negligent and intentionally endangered users’ health by releasing it into the market while knowing of the associated risks.

The saxagliptin heart failure lawsuit states that since the drug was released onto the market, there have been numerous reports of patients who use the drugs experiencing heart failure. Additionally, another drug, Avantia, which functions in much the same way as Onglyza and Kombiglyze XR, was recalled after it posed too high a risk to users’ cardiac health.

Shirley claims that Onglyza and Kombiglyze XR’s manufacturers did not conduct sufficient research to investigate the impacts of such an alteration to a natural hormone cycle. According to Shirley, they should have conducted studies to determine if this increased insulin production could negatively impact cardiovascular health, and were negligent in not doing so.

Additionally, the saxagliptin heart failure lawsuit states that individuals with type-2 diabetes have, in general, a higher risk of cardiac failure than other individuals. In December 2008, the FDA published guidelines for companies on developing anti-diabetic drugs with cardiac health in mind.

Allegedly, “despite this guidance being issues during the development of [Onglyza and Kombiglyze XR, Bristol-Myers and others] failed to perform adequate clinical trial stop determine if their drugs created such an increased risk,” Shirlye says. The lawsuit goes on to state that the companies marketed and sold the drugs for nearly five years without completing a robust study of the drugs’ impact on cardiac health.

The Onglyza and Kombiglyze XR Saxagliptin Heart Failure Lawsuit is Case No. 4:18-cv-00186-TCK-JFF, in the U.S. District Court for the Northern District of Oklahoma.