Hundreds of lawsuits involving cardiac side effects allegedly associated with Onglyza continue to move forward in a multidistrict litigation now underway in the U.S. District Court, Eastern District of Kentucky.
According to a Case Management Order dated December 11th, the Court has revised deadlines governing general causation discovery:
Onglyza (saxagliptin) is indicated to lower blood sugar levels in patients with Type 2 diabetes.
The medication was approved by the U.S. Food & Drug Administration (FDA) in 2009. The following year, the agency cleared sales of Kombiglyze XL, a combination drug that contains saxagliptin and metformin.
When Onglyza was approved, the FDA ordered a post-market study to better assess its potential heart risks, including, congestive heart failure, cardiac failure, and death related to those events. The results of that study — SAVOR TIMI 53 – were published in 2013 and indicated that patients treated with saxagliptin had a statistically significant increased risk of being hospitalized for heart failure.
In April 2015, an FDA advisory panel voted 14 to 1 to recommend new heart failure warnings for saxagliptin-containing medications. The single dissenting advisor wanted the agency to go even further, arguing that Onglyza and Kombiglyze XR should be withdrawn from the market.
A year later, the FDA confirmed that saxagliptin might increase the risk of heart failure, especially in patients with pre-existing heart or kidney disease. AstraZeneca was ordered to add new heart failure warnings to the Onglyza and Kombiglyze labels.
More than 260 Onglyza and Kombiglzye lawsuits are now pending in the Eastern District of Kentucky.
Plaintiffs claim that AstraZeneca and other defendants were aware of saxagliptin’s potential to harm the heart long before the FDA ordered the labels updated, but continued to promote Onglyza and Kombiglyze XAR as safe treatments for Type 2 diabetes. They further assert that the current label warnings do not adequately address the potential risk for heart failure, congestive heart failure, cardiac failure, and death, despite the findings from the SAVOR TMI 53 study.
Daniel C. Burke, a partner with Bernstein Liebhard LLP, is serving on the Plaintiffs’ Executive Committee for the Onglyza and Kombliglyze litigation.