Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) are both drugs that are used to treat Type 2 diabetes by controlling blood sugar levels. The drug mimics hormones that encourage the pancreas to produce more insulin, lowering blood sugars in diabetic patients. Sold by AstraZeneca and Bristol-Myers Squibb, Onglyza was first approved by the FDA in 2009 and Kombiglyze XR in 2010.
There have been reports of dangerous side effects caused by the drugs.
Serious health risks caused by Onglyza and Kombiglyze XR:
In February 2014, the FDA issued a Drug Safety Communication, and opened an investigation into the link between saxagliptin and heart failure. The FDA requested clinical trial data from the saxagliptin manufacturer. The request was prompted by a study funded by the manufacturer published by the New England Journal of Medicine (NEJM) that reported 27% increased rate of hospitalization for heart failure after taking the drug.
In April 2015, an FDA panel voted overwhelmingly in favor of adding warnings of heart failure risks, all-cause mortality, decreased renal function, and acute pancreatitis in the labels for Onglyza and Kombiglyze XR. Since then, the labels have been updated with warnings about severe and disabling joint pain (in August 2015), pancreatitis, and heart failure (in April 2016).
Thousands of patients may have experienced heart failure and other significant risks associated with Onglyza and Kombiglyze XR.
If you have experienced heart failure or other injuries after taking the drug Onglyza or Kombiglyze XR, explore your options with our defective drug attorneys at Kaiser Gornick LLP. We are a national product liability firm at the forefront of litigating against negligent pharmaceutical companies.