An Onglyza heart failure lawsuit has been filed alleging that the type-2 diabetes medication can cause heart problems including heart failure.

Plaintiff Catina L. filed this Onglyza heart failure lawsuit against Bristol-Myers Squibb Company, Astrazeneca Pharmaceuticals LP, and McKesson Corporation, alleging that the type-2 diabetes medication can cause heart failure, congestive heart failure, and death.

Catina alleges she was prescribed Onglyza and later suffered from heart failure. The Onglyza heart failure lawsuit argues that the heart failure was a direct result of taking the diabetes medication.

Onglyza (saxagliptin) is a type-2 diabetes medication prescribed to help lower blood sugar levels. The drug triggers chemical responses in the body that induce insulin secretion.

“[Onglyza] manipulates the natural biological incretin effect by enabling the process to continue for an exponentially greater period of time than what the human body has adapted as a sufficient and safe period of time,” the Onglyza heart failure lawsuit claims.

In December 2008, the U.S. Drug and Food Administration (FDA) issued guidance to companies developing anti-diabetic drugs in the form of a memorandum, entitled Final Guidance for Industry, Diabetes Mellitus: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. Because diabetic patients are at higher risk for cardiovascular events, the FDA stated that new diabetes drugs needed to demonstrate that they don’t demonstrate an unacceptable cardiac risk.

Bristol-Myers allegedly did not conduct this testing until after they had marketed their products in 2009 and 2010, according to Catina’s lawsuit. She says that when the company finally did conduct clinical testing on the drug, the Cardiovascular Outcome Trial, entitled SAVOR, found that Onglyza users had a much higher risk of being hospitalized due to heart failure.

After receiving the shocking results of the SAVOR trial, the FDA requested the raw clinical data and conducted its own analysis. Once they had confirmed the findings of the SAVOR trial with their own analysis, the FDA Endocrinologic and Metabolic Drugs Advisory Committee allegedly voted to add a heart failure warning to the drug’s label. One member of the committee allegedly voted to have the drug removed from the market completely due to the cardiovascular risks. According to the Onglyza heart failure lawsuit, Bristol-Myers failed to add a warning to the drug’s label despite the FDA’s decision.

The Onglyza heart failure lawsuit claims that Catina, other patients, and medical professionals would not use Onglyza if they had been properly warned of the risks associated with the medication.

“Despite the SAVOR findings and despite the FDA Advisory Committee voting to add a warning (or remove drugs from the market), Defendants failed and continue to fail to warn. Once again, Defendants place sales over patient safety,” the Onglyza heart failure lawsuit accuses.

Catina accuses the manufacturers of design defect, negligence, and failure to warn. The Onglyza heart failure lawsuit seek compensatory damages, consequential damages, non-economic damages, wrongful death damages, disgorgement, restitution, punitive damages, court costs, and attorneys’ fees.

The Onglyza Heart Failure Lawsuit is Case No. 1:18-cv-00061-SA-DAS in the United States District Court for the Northern District of Mississippi.