November 5, 2015 — A woman from Chicago has filed a wrongful death lawsuits against AstraZeneca after her mother died from heart failure after taking Onglyza.
The lawsuit was filed on October 29 in Cook County Circuit Court (Case No. 2015-L-010969) by Rochelle Gibson, daughter of Lille Ree Gibson.
According to the complaint, Lillie Ree Gibson was prescribed Onglyza in 2010 for the treatment of type-2 diabetes. The drug allegedly caused her to develop severe heart problems. She was diagnosed with heart failure in June 2011 and hospitalized twice before her death in October 2013.
In April 2015, an expert panel to the FDA recommended new safety warnings about heart failure from Onglyza. The panel also asked for more data on the higher all-cause mortality risk observed during the SAVOR clinical trial.
The SAVOR study also found a 27% increase in the rate of first hospitalizations for heart failure associated with Onglyza, according to MedPage Today.
People with type-2 diabetes have a higher risk of developing heart problems as a result of their disease, which is one reason why the FDA is so concerned about medications that increase this risk even further.
In October 2015, the FDA rejected approval of a new diabetes drug that combined Onglyza with Farxiga (dapagliflozin). Earlier this year, the FDA warned that Farxiga can lead to diabetic ketoacidosis, a life-threatening side effect in which the blood is too acidic.
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