A consumer recently filed a lawsuit against Bristol-Myers Squibb, alleging that Onglyza caused her deceased husband to suffer from congestive heart failure.

Plaintiff Phyllis M. recently filed a lawsuit on behalf of her deceased husband, Charles M., against Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals LP, alleging that Onglyza caused Charles to suffer from congestive heart failure.

According to Phyllis’s lawsuit, Charles ingested Onglyza for treatment of diabetes from June 2012 to July 2016. She says that in October 2015, Charles developed congestive heart failure. The lawsuit claims that his development of congestive heart failure was a direct result of his prolonged treatment using Onglyza.

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

“[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 congestive 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 cardiovascular death is the number one killer of the diabetic population, the FDA determined 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 Phyllis. “Defendants ignored patient safety and sold [Onglyza] before studying the risks,” the lawsuit states. “Defendants marketed and sold [Onglyza] for nearly five years before completing an adequately powered and design study of the risks of heart failure, congestive heart failure, cardiac failure, and death related to those events.”

When the company finally did conduct clinical testing on the drug, the Cardiovascular Outcome Trial, entitled SAVOR, found that Onglyza users had a higher risk of being hospitalized due to heart failure. After receiving the 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 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. “Defendants, with knowledge of the true relationship between use of [Onglyza] and heart failure, congestive heart failure, cardiac failure, and death related to those events, promoted and continue to promote [Onglyza] as a safe and effective treatment for type 2 diabetes,” the lawsuit states.

The lawsuit seeks compensatory damages, punitive damages, court costs, and attorneys’ fees.

The Onglyza Lawsuit is Case No. 2:18-cv-00407-ALM-KAJ in the United States District Court for the Southern District of Ohio.