Bristol Myers and Otsuka Pharmaceuticals are facing a new Onglya lawsuit from a man alleging he developed signs of heart problems and congestive heart failure.

This man claims that he was not properly warned of the alleged correlation between Onglyza and cardiovascular complications, and that as a result he ignored signs of heart problems.

Plaintiff Robert E. alleges he was prescribed Onglyza for typical type-2 diabetes treatment, and had no reason to be vigilant for any signs of heart problems at the time. Onglyza is a part of the incretin mimetic drug family, which works by stimulating the pancreas to make more insulin.

Type-2 diabetes patients often have difficulties in producing sufficient insulin levels which are necessary for the body’s metabolic process. Along with diet and exercise, Onglyza is supposed to help patients live as normal of a life as possible while minimizing their type-2 diabetes symptoms.

With these benefits in mind, Robert says he was prescribed Onglyza on Sept. 30, 2013 and took the medication according to prescription instructions and his physician’s advice.

During the course of his prescription, Robert says he did not use the medication for anything outside of its intended purpose and received no disclosures from the pharmaceutical companies regarding signs of heart problems.

However, Robert reportedly developed congestive heart failure sometime after starting his Onglyza prescription and was taken off the drug on Jan. 7, 2016. According to the Onglyza lawsuit, Robert suffered a cardiac episode on March 14, 2014 and had to be hospitalized for the event.

While he survived after receiving emergency treatment, Robert was surprised to discover that Onglyza was linked to an increased risk of cardiac death.

Overview of Onglyza Heart Problems

Cardiac complications were not a widespread concern with Onglyza and other saxagliptin medications until after type-2 diabetes drug, Avandia, was recalled from the market for an increased risk of cardiac death.

In 2015, an FDA panel voted to require AstraZeneca to update Onglyza’s warning label to include potential heart failure as a possible side effect. The FDA made this decision after reviewing data from the SAVOR study, which consisted of 16,000 patients that were prescribed different type-2 diabetes medications.

Out of the 16,000 patients, approximately 1,222 patients reportedly developed serious cardiac complications. While the results of the study showed an occurrence rate of 27 percent, this was not considered statistically significant. But the FDA still voted to include potential heart failure as a possible side effect.

Heart failure is a serious health condition that occurs when the cardiac muscle becomes too weak to pump blood and can be caused by a number of different conditions like high blood pressure or coronary artery disease. Patients who are at risk for this condition should be vigilant for any signs of heart problems including:

• Breathing difficulties
• Fatigue
• Swelling in hands, feet or ankles
• Persistent coughing
• Wheezing
• Irregular heart beat

Even though heart failure can be potentially fatal, Bristol Myers and Otsuka allegedly failed to warn the general public. Robert states he would not have agreed to take the medication if he had known about the alleged link between Onglyza and heart failure.

Robert also states he would have been vigilant for the signs of heart problems if he had been aware of the alleged correlation.

This Onglyza Lawsuit is Case No. 5:18-cv-00372-KKC, in the U.S. District Court of Eastern Oklahoma.