Onglyza Wrongful Death Lawsuit Filed Over Heart Failure From Saxagliptin Drug

Side effects of saxagliptin, which is contained in the diabetes drugs Onglyza and Kombiglyze XR, allegedly caused a Nevada man’s wrongful death due to heart failure, according to a recently filed lawsuit.

The complaint (PDF) was brought by Elke Mounteer in the U.S. District Court for the District of New Jersey on September 14, indicating that the drug makers failed to adequately warn about the risk of heart failure from Onglyza, which resulted in the death of her husband, Peter Otrebski.

According to the wrongful death lawsuit, Otrebski was prescribed Onglyza and Kombiglyze XR at various times between 2015 and 2017. The side effects of the drugs ultimately resulted in coronary artery disease, congestive heart failure, and death, which the complaint indicates are known risks that Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals should have warned consumers and the medical community about.

Learn More About

Onglyza Lawsuits

“At all relevant times, Defendants acted in concert with one another to fraudulently convey false and misleading information concerning the safety and efficacy of Saxagliptin and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure and other adverse effects associated with Saxagliptin from the public, Decedent, Decedent’s physicians, and other healthcare providers,” the lawsuit states.

AstraZeneca and Bristol Myers Squibb jointly developed Onglyza, introducing the type 2 diabetes treatment in 2009. Kombilgyze XR is a combination treatment that contains saxagliptin from Onglyza together with the older diabetes drug metformin.

Although it has been marketed as safe and effective, concerns have emerged in recent years about potential risk of heart damage, resulting in a number of similar Onglyza lawsuits being filed by former users in courts nationwide.

The litigation emerged after the FDA launched an investigation into the heart risks with Onglyza in 2014, following the publication of a study, known as “SAVOR”, in the New England Journal of Medicine. However, the lawsuit filed by Barrientes claims that clinical trials showed that users had a significantly increased risk of being hospitalized for heart failure as far back as 2008, a year before Onglyza was introduced.

In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart side effects, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality.

The review looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.

Mounteer’s case will be consolidated with other Onglyza cases pending in the federal court system, which were combined as part of a federal MDL, or multidistrict litigation, earlier this year for coordinated discovery and pretrial proceedings. The litigation is centralized before U.S. District Judge Karen K. Caldwell in the U.S. District Court for the Eastern District of Kentucky.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits
Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits (Posted today)

Abbott Laboratories is considering removing Similac infant formula products designed for preterm babies from the market, as it faces hundreds of lawsuits claiming the products increase the risk of necrotizing enterocolitis, which puts newborns at a high risk of permanent injuries and death.

Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL
Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL (Posted yesterday)

A federal judge has ordered parties involved in Suboxone dental decay lawsuits to submit proposals for exchanging information that will guide the selection of representative bellwether claims for early test trials.

Master Baby Food Lawsuit Filed in MDL Outlines How Toxic Metals Caused Autism, ADHD in Children
Master Baby Food Lawsuit Filed in MDL Outlines How Toxic Metals Caused Autism, ADHD in Children (Posted 4 days ago)

Plaintiffs have submitted a baby food lawsuit Master Complaint that is expected to streamline the filing of lawsuits alleging that toxic heavy metals in Beech-Nut, Gerber, Hain and Nurture products caused ADHD, autism and other developmental disorders.