A new Onglyza lawsuit claims that the Type 2 diabetes medication caused a Chicago woman’s wrongful death from heart failure. The complaint, which is currently pending in Cook County Circuit Court in Illinois, asserts that AstraZeneca Pharmaceuticals failed to warn patients that Onglyza could increase their risk for the potentially deadly condition.
According to the lawsuit, the decedent began taking Onglyza in 2010, per her doctor’s orders to control Type 2 diabetes. She was diagnosed with heart failure in June 2011, which resulted in two hospitalizations in 2013. The woman passed away from the condition on October 31, 2013.
Onglyza is a DPP-4 inhibitor (saxagliptin) that belongs to a class of Type 2 diabetes medications called incretin mimetics. The medication was approved for sale by the U.S. Food & Drug Administration (FDA) in 2009, with sales reaching $709 million by 2012.
In February 2014, the FDA issued an Onglyza safety alert, after a study indicated that patients exposed to saxagliptin were 27% more likely to be hospitalized for heart failure compared to those who had not taken the medication. The trial, known as SAVOR-TMI 53, involved more than 16,000 patients, and was intended to determine whether or not saxagliptin provided any protective cardiovascular benefits in addition to lowering blood glucose levels.
In April 2015, the FDA convened a meeting of outside medical advisors to further investigate the possible link between Onglyza and heart failure. The panel voted 14-1 to recommend that new safety information regarding an increased risk of heart failure be added to the labels Onglyza, as well Kombiglyze XR, another AstraZeneca drug that combines saxagliptin with metformin.
The FDA is not required to enact the recommendations of its advisory panels, but in most cases it does so. It is not known when the agency might make a final determination in regards to Onglyza and heart failure.
Bernstein Liebhard LLP is currently offering free legal reviews to individuals who were allegedly hospitalized for heart failure due to Onglyza, as well as their surviving family members. If you would like to explore the possibility of filing an Onglyza lawsuit, please contact our office by calling today.