Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals LP face a recent Onglyza side effects lawsuit filed by a woman alleging that the type-2 diabetes drug caused her to suffer severe adverse side effects and complications.

Plaintiff Kelley M. files the Onglyza side effects lawsuit in New York federal court demanding jury trial. The lawsuit was filed on March 28, 2018.

According to the Onglyza side effects lawsuit, Kelley, a resident of California, took Onglyza between August 2012 and October 2016. However, she says that after use she “suffered bodily and mental injuries, pain and suffering, mental anguish, embarrassment, inconvenience, loss of earnings and earning capacity, and have and will incur past and future medical expenses.”

Kelley also claims her physicians would not have prescribed Kelley Onglyza, and would have changed the way they warned her about the serious side effects and complications linked to the medication. They state that they would have discussed with her “the true risks of heart failure, congestive heart failure, cardiac failure, and death” related to Onglyza.

Kelley’s physicians say that the manufacturers failed them in providing “appropriate and adequate” warnings of the risks associated with their medication.

The Onglyza side effects lawsuit was filed on multiple counts including design defect, negligence, failure to warn, breach of warranty of merchantability, breach of express warranty, and breach of implied warranty.

Overview: Onglyza Side Effects

In recent years, thousands of plaintiffs have filed Onglyza side effects lawsuits after suffering complications that have included congestive heart failure, cardiac failure, or heart failure. The drug’s manufacturers are being accused of knowing full well the relationship between Onglyza and heart failure while continuing to promote Onglyza as a safe and effective treatment medication for type-2 diabetes.

The drug was first approved by the U.S. Food and Drug Administration (FDA) in 2009. Like all drugs, Onglyza has side effects. Other reported complications have included inflammation of the pancreas, low blood sugar, joint pain, allergic and skin reactions, vomiting, headaches, urinary tract infections, diarrhea and upper respiratory tract infection.

Impact of Onglyza Ingredients

Onglyza consists of saxagliptin, an active ingredient and a DPP-inhibitor. It is an enzyme that breaks down GLP-1, a hormone that becomes released into the bloodstream after digestion. What GLP-1 does is signal insulin to become released from the pancreas; what Onglyza does is inhibit DPP-1 from breaking down GLP-1, thus allowing it to stay in the body longer and allowing insulin release after ingestion.

In 2014, however, a safety announcement was released by the FDA stating that in a safety review it was found that “type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”

The FDA advisory committee required Onglyza’s manufacturer to include a warning label informing consumers of Onglyza’s heart failure risks, but for many, like Kelley, the warning came too late.

The Onglyza Side Effects Lawsuit is Case No. 5:18-cv-00449-KKC, in the U.S. District Court for the Southern District of New York.