Texas Woman Seeks to Hold Manufacturers Liable for Onglyza Heart Failure

A Texas woman blames Onglyza (saxagliptin) for serious injuries she suffered after taking the medication to treat her type 2 diabetes. She recently filed a new lawsuit in the District Court of Dallas County, Texas, bringing claims against manufacturers Bristol-Myers Squibb and AstraZeneca.

Plaintiff Blames Onglyza for Heart Failure and Respiratory Failure

According to her complaint, the plaintiff started taking Onglyza in August 2013 and continued to take it through December 2015. She says that while taking it, she developed serious adverse effects including heart failure, congestive heart failure, and acute hypoxic respiratory failure. The plaintiff says the defendants knew that their product increased the risk of these conditions, but failed to provide adequate warnings to patients and doctors.

The plaintiff also states that had her doctors been aware of the risks, they wouldn’t have prescribed Onglyza and, instead, would have changed the way they treated her condition, or would have at least warned her about the drugs’ serious adverse effects.

The plaintiff blames Onglyza manufacturers for her injuries and says that because of the defendants’ failures, she has suffered injuries, related medical expenses, lost income and wages, diminished earnings potential, and other losses.

Manufacturers Add Heart Failure Warnings After Seven Years

The FDA first started investigating Onglyza in February 2014. They asked to see the data from a post-marketing test the manufacturers had conducted on the drug, so they could evaluate it themselves. The study had reported an increased risk for heart failure in patients using Onglyza. Yet this study was not conducted nor evaluated until after the manufacturers had already been selling the product for years (the drug was released in 2009).

The FDA initially considered the results to be preliminary, but after they finished their evaluation of the data, they released another safety communication in April 2016 warning that both saxagliptin and alogliptin could increase the risk of heart failure, particularly in patients who already had heart or kidney disease. Because of these findings, they required the manufacturers to add new warnings to the product label about these risks.

The product had been on the market for nearly seven years.

Plaintiff Joins Many Others with Complaints About Onglyza

Onglyza and other drugs like it are part of a class of medications called “dipeptidyl peptidase-4 (DPP-4) inhibitors,” which are used to help lower blood sugar levels in adults with type 2 diabetes. They work by stimulating the pancreas to make more insulin after a meal. The insulin, in turn, helps process more glucose so it doesn’t remain in the blood.

Back in 2008, the FDA warned companies making diabetes drugs to study them in people with cardiovascular disease since diabetes increases heart problem risks. Yet, the Onglyza manufacturers allegedly ignored that advice until after the product was on the market, where it could potentially harm patients.

The plaintiff brings negligence, failure to warn, and breach of warranty claims, and seeks both compensatory and punitive damages. Her case joins a growing number of others filed by plaintiffs with similar complaints. In February 2018, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally-filed Onglyza lawsuits into one court in the Eastern District of Kentucky.