A new lawsuit alleges that type-2 diabetes drug Onglyza was the cause of the complainant’s congestive heart failure.

Plaintiff Georgia C. registered her legal claim against the Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, IPR Pharmaceuticals Inc., and the McKesson Corp., manufacturers and distributors of the drug, saying they not only failed to warn, but were negligent in their duties to perform adequate safety testing of Onglyza

By virtue of the diagnosis of type-2 diabetes, Georgia was purportedly automatically at risk for the development of cardiovascular disease issues, such as congestive heart failure. According to reports, heart problems are the biggest problem leading to early death among this population.

Because of this risk, the U.S. Food and Drug Administration (FDA) sent out guidance for drug manufacturers creating treatments for diabetes. The memorandum indicated that they must verify that cardiovascular risk is not ramped up by the ingestion of any medication used for medical management of the disease.

History of Onglyza

Onglyza—known generically as saxagliptin—became commercially available in the late summer of 2009. Georgia says in her lawsuit that despite the guidance of the FDA, cardiovascular studies were not undertaken, and adequate warnings relating Onglyza with congestive heart failure were not given until the diabetes drug had secured a sizable profit over a five-year period.

Eventually, the SAVOR trial was undertaken and generated data pointing to increased risk of hospitalization for congestive heart failure tied to saxagliptin ingestion. An FDA advisory panel voted to require a label warning, but the drug wasn’t removed from the market, according to Georgia’s case narrative.

Georgia says she took Onglyza for nearly three years, from April 2013 to January 2016. She allegedly suffered serious injury connected but not limited to congestive heart failure. Treatment for this condition has expended most of her financial resources. She believes that if her physician had been adequately apprised of the cardiovascular risk, another drug choice would have been made as they consulted with one another.

What is Congestive Heart Failure?

According to Healthline, congestive heart failure is a progressive condition in which the pumping power of the heart muscle is compromised. The inefficiency of the lower two chambers of the heart which send oxygenated blood to organs and tissues lend to fluid backup in the lungs, lower extremities, abdomen, and liver.

Studies have reported that saxagliptin may increase the risk of hospitalization for heart failure by 27 percent. By all measurements, it does not decrease the risks of experiencing a myocardial infarction—heart attack—or stroke.

Plaintiff Georgia is seeking compensatory, statutory, and punitive damages from the defendants for their alleged negligence in marketing and seeking profit from a potentially dangerous drug.

Her Onglyza lawsuit is Case No. 5:19-cv-00025-KKC, filed in U.S. District Court for the Eastern District of Kentucky, Central Division at Lexington.