Bristol Myers Squibb and AstraZeneca Pharmaceuticals LP are facing a growing number of claims alleging serious saxagliptin side effects, including instances of heart failure.

Reports suggest these instances could be linked to saxagliptin, the core ingredient of the popular type-2 diabetes drug Onglyza. One of the most recent Onglyza lawsuits alleging heart failure caused by saxagliptin side effects was filed by a man from West Virginia.

Plaintiff Gary S. says he was prescribed Onglyza for typical type-2 diabetes treatment purposes and had taken the medication according to prescription instructions and physician’s advice.

Gary says he started his Onglyza prescription in January 2016 and stayed on the medication until March 2018. During the course of his prescription, Gary allegedly developed saxagliptin side effects including congestive heart failure.

According to the Onglyza lawsuit, Gary was diagnosed with congestive heart failure in July 2017.

Overview of Onglyza Lawsuit

Onglyza is part of the incretin mimetic drug family, which works by signaling the pancreas to increase insulin production in type-2 diabetes patients. With proper insulin levels, the body is able to maintain proper metabolic function and will help offset serious diabetic complications like amputation or diabetic coma.

Without proper insulin, the body is forced to metabolize fat instead of sugar and causes the blood to become very acidic. This can lead to the development of diabetic ketoacidosis or kidney failure. Combined with diet and exercise, Onglyza is supposed to help patients live a healthy lifestyle and have greater longevity.

Onglyza was approved by the FDA in July 2009, and quickly became popular with the type-2 diabetes patient population.

However, certain type-2 diabetes drugs came under scrutiny when Avandia was recalled for allegedly increasing the risk of heart failure. This concern spurred Bristol Myers and AstraZeneca to fund a study analyzing the risk of saxagliptin side effects, including the drug’s alleged correlation to heart failure.

This SAVOR study was published in the New England Journal of Medicine in 2013, after examining records of 16,492 type-2 diabetes patients. This study was reportedly done to help doctors evaluate saxagliptin side effects and help determine which medications are right for patients.

The study found that Onglyza patients faced a slightly higher risk of being hospitalized for heart failure, compared to patients prescribed other type-2 diabetes medications.

While there was a slight increased risk of heart failure in Onglyza patients, the results were not considered statistically significant. However, researchers believe further investigation is needed into the alleged correlation between heart failure and saxagliptin side effects.

In April 2015, an FDA advisory committee reportedly urged the agency to order AstraZeneca and Bristol Myers to include information about the potential risk of heart failure. Even though heart failure is a potentially deadly medical condition, patients like Gary say AstraZeneca and Bristol Myers allegedly failed to warn the general public.

At all times relevant, Gary says he relied on the marketing materials and product information and was not aware of the alleged correlation of saxagliptin side effects with heart failure. Gary states he would not have agreed to take Onglyza if he was aware of the potential saxagliptin side effects.

This Onglyza Lawsuit is Case No. 2:18-cv-03732-JD, in the U.S. District Court for the Eastern District of Pennsylvania.