A diabetes patient says that Bristol-Myers Squibb didn’t advertise the link between diabetes med Onglyza and heart failure.

Onglyza and Kombiglyze XR are drugs used to treat type-2 diabetes and are made by Bristol-Myers Squibb. They are brand names of rate drug saxagliptin, which works to treat type-2 diabetes by lowering the blood sugar of a diabetes patient.

Plaintiff Kathy A. says that she took saxagliptin manufactured by Bristol-Myers Squibb approximately between December 2014 and June 2017 to manage her type-2 diabetes. She claims that as a result of her saxagliptin use, she developed heart failure, congestive heart failure, and cardiovascular injury. She says she was never told about Onglyza and heart failure. 

She aims to hold Bristol-Myers Squibb accountable for her injuries, claiming that the company knew or should have known that the drug could cause heart failure, but marketed it nonetheless. Kathy seeks damages for her injuries, claiming that her injuries were permanent and/or serious.

Additionally, she claims that her heart problems that allegedly resulted from her saxagliptin use caused her both emotional and financial injury, as well as physical injury. Allegedly, she was caused pain and suffering because of her heart problems, and suffered financial injury because of the medical bills she incurred trying to deal with her health problems.

Kathy says that Bristol-Myers Squibb knew that Onglyza and heart failure were linked, but continued to sell the drugs nonetheless in order to increase their profits.

According to the Onglyza and heart failure lawsuit, the FDA issued a warning in December 2008 that warned diabetes drug makers that any new drugs made to treat diabetes should not increase a patient’s risk of heart problems, because diabetes patients already have a higher risk of heart problems than most people do.

Allegedly, this guidance was issued while Bristol-Myers Squibb was developing Onglyza and Kombiglyze XR. Kathy claims that the drug company failed to perform adequate trails on the drug’s safety before releasing it onto the market, and in so doing, exposed patients to a risk of heart failure.

The Onglyza and heart failure lawsuit claims that Bristol-Myers Squibb sold saxagliptin drugs for almost five years before the company completed an “adequately powered and designed study of the risks of heart failure, congestive heart failure, cardiac failure, and death related to those events.”

Kathy states that saxagliptin lowers blood sugar by inhibiting natural enzymes from stopping the production of insulin when it would naturally be stopped in a diabetic person, allowing the production of insulin to continue longer than it otherwise would be produced after a patient has eaten.

However, the Onglyza and heart failure lawsuit argues that the drug company failed to examine how changing a patient’s metabolism in this way affected their body on a systemic level, and how this change might affect cardiac health in patients who are already at risk for heart problems.

The Onglyza and Heart Failure Lawsuit is Case No. 5:18-cv-00635-KKC, in the U.S. District Court for the Eastern District of Kentucky Central Division at Lexington.