A disgruntled consumer recently filed a lawsuit against numerous pharmaceutical companies, alleging that they failed to warn consumers of risks and concealed the link between saxagliptin and congestive heart failure.

Plaintiff Perry B. recently filed a lawsuit against Bristol-Myers Squibb, AstraZeneca, and McKesson, alleging that the pharmaceutical companies concealed the link between saxagliptin, the active ingredient in Onglyza, and congestive heart failure.

Perry says he took took saxagliptin from May 2014 until January 2017 after being prescribed the drug by his physicians. In March 2018, Perry alleges he was diagnosed with congestive heart failure. He believes that his use of saxagliptin and congestive heart failure diagnosis are related.

Saxagliptin, sold under the brand names Onglyza and Kombiglyze XR, is a drug used to lower blood sugar levels in patients with type-2 diabetes. The drug works to lower blood sugar by interfering with chemical processes to induce glucose-dependent stimulation of insulin secretion. However, this process is allegedly dangerous and its side effects on biological processes are not understood.

“Saxagliptin 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 lawsuit claims.

The “drastic alterations of the natural incretin hormone cycle” can allegedly lead to an increased risk of cardiac events such as congestive heart failure. The link between saxagliptin and congestive heart failure has been supported by scientific evidence, including a study mandated by the U.S. Food and Drug Administration (FDA).

Because diabetic patients are at a higher risk for a cardiac event, the FDA has recently put a special emphasis on the cardiac outcomes of diabetic medications such as saxagliptin. The FDA recommended that the defendants conduct a cardiac outcome study in 2008 and they finally followed through on this recommendation years later, after they had started marketing Onglyza and Kombiglyze XR.

The SAVOR (“Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus — Thrombolysis in Myocardial Infarction 53”) conducted by the defendants allegedly showed that there was a statistically significant link between saxagliptin and congestive heart failure, with patients having an increased risk of being hospitalized for the cardiac complication.

After seeing these results, an FDA advisory committee allegedly recommended that the defendants add a warning label about the link between saxagliptin and congestive heart failure. However, the defendants allegedly chose to “place sales over patient safety” and failed to add a warning.

Perry claims that the defendants had a duty to warn their consumers about the link between saxagliptin and congestive heart failure, but shirked that duty and prioritized their own monetary success over patient health.

“Defendants, with knowledge of the true relationship between use of Saxagliptin and heart failure, congestive heart failure, cardiac failure, and death related to those events, promoted and continue to promote Saxagliptin as a safe and effective treatment for type-2 diabetes mellitus,” the lawsuit claims.

Perry accuses the defendants of breach of warranties, design defect, negligence, and failure to warn. The saxagliptin and congestive heart failure lawsuit seeks compensatory damages, consequential damages, non economic damages, punitive damages, restitution, disgorgement, court costs, and attorneys’ fees.

The Saxagliptin and Congestive Heart Failure Lawsuit is Case No. 2:18-cv-03730-JD in the United States District Court for the Eastern District of Pennsylvania.