A Texas woman has filed a saxagliptin heart failure lawsuit against Bristol-Myers Squibb Company, AstraZeneca Pharmaceuticals LP, and McKesson Corporation claiming that the ingestion of the type-2 diabetes treatment drugs Onglyza and Kombiglyze XR may lead to heart failure or other cardiovascular problems.

Plaintiff Sonia N. claims that she developed serious and permanent injuries including heart failure, congestive heart failure, and cardiovascular injury due to her ingestion of saxagliptin. As a result of these injuries, she claims to have also suffered bodily and mental injuries, pain and suffering, embarrassment, and loss of earnings and earning capacity, as well as incurring medical expenses.

In her saxagliptin heart failure lawsuit, Sonia is demanding damages from each defendant including: all available compensatory damages, past and future medical expenses including life care, past and future lost wages and loss of earning capacity, past and future emotional distress, noneconomic damages including pain, suffering, and loss of enjoyment of life, restitution, disgorgement of profits, attorneys’ fees, and punitive damages.

Onglyza and Kombiglyze XR both contain the drug saxagliptin. These drugs work in conjunction with diet and exercise to control blood sugar levels in patients with type-2 diabetes by stimulating the pancreas to create insulin.

Type-2 diabetes is characterized by insulin resistance and insufficient natural insulin secretion. This leads to high blood sugar levels, also called hyperglycemia. People with type-2 diabetes are at increased risk for cardiovascular disease. Therefore, it is important that type-2 diabetes drugs do not increase this risk further.

Despite a recommendation from the FDA in 2008 to conduct a Cardiovascular Outcome Trial (CVOT) regarding saxagliptin, Onglyza and Kombiglyze XR were introduced to the market in 2009 and 2010 without one.

The saxagliptin heart failure lawsuit alleges that this refusal to comply with FDA recommendations, as well as inadequate research into the possible cardiovascular side effects of the drug, shows that the corporations had little regard for the health and safety of their patients. Sonia says that for almost five years, the corporations named in the saxagliptin heart failure lawsuit marketed and sold these drugs to the public before conducting a CVOT to study the possible cardiovascular risks.

When a CVOT was finally conducted, the results showed that patients who had been prescribed saxagliptin were at a statistically significant increased risk for heart failure and cardiovascular injury. In response, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted almost unanimously to add a heart failure warning label to the drug. The single dissenting member of the committee who voted against the warning stated that the drug should be removed from the market entirely.

Despite the FDA committee’s decision, the lawsuit alleges that the corporations continued to fail to warn the public of the possible dangers of saxagliptin, and continued to market it as a safe and effective way to control type-2 diabetes.

Sonia’s Saxagliptin Heart Failure Lawsuit is Case No. 5:18-cv-00634-KKC, in the U.S. District Court for the Southern District of New York.