Onglyza/Kombiglyze XR (Saxagliptin)
Why are Type 2 Diabetics Suing the Manufacturers of Onglyza and Kombiglyze XR?
Onglyza (Bristol-Myers Squibb (“BMS”)) and Kombiglyze XR (AstraZeneca (“AZ”)) are saxagliptin-based drugs used to control blood sugar levels for people suffering with type 2 diabetes. These drug manufacturers have been named as defendants in lawsuits filed by diabetics, alleging that Onglyza and/or Kombiglyze XR caused them heart failure. (Read more on how Onglyza, Kombiglyze XR, and other similar medications have been linked to causing pancreatic cancer. Diabetes Drugs Linked to Causing Pancreatic Cancer)
In 2008 the Federal Food and Drug Administration (“FDA”) required diabetes drug manufacturers to test for unacceptable risks of cardiovascular events. But, BMS and AZ began marketing these drugs as safe and effective before conducting the safety studies. Even when there was an increased report of the risk of heart failure, BMS and AZ continued to promote these drugs as safe and effective. They chose to leave their warning labels unchanged, failing to include warnings of heart failure.
Reliable scientific studies reviewed by the FDA revealed that there is a 27% increased risk of heart failure for those taking saxagliptin-based drugs. In April of 2016, the FDA required manufacturers to add a black box warning to the labels of these medications. That warning advises that the use of saxagliptin-based drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” FDA Safety Advisory.
What is Heart Failure?
Heart failure is the heart’s inability to pump enough blood to meet the body’s needs. Ejection fraction is the measurement of the amount of blood pumped out of the left side of the heart with each heartbeat. A normal ejection fraction is 55% (or greater). The ejection fraction of someone in heart failure is 40%, or less. Symptoms of heart failure include:
- shortness of breath during daily activities
- difficulty breathing when lying down
- weight gain with swelling in the ankles, feet, legs, and/or stomach.
Heart failure is permanent and can lead to cardiac arrest, congestive heart failure, and death. As a result, once diagnosed, treatment and management of heart failure is lifelong.
How is Heart Failure Diagnosed?
You need to make an appointment with your cardiologist to determine if you are experiencing heart failure. Physicians take into account medical history, a review of symptoms, and a physical exam. They also consider the results of certain diagnostic studies, to confirm whether you have heart failure. Studies used to diagnose heart failure include: bloodwork; chest x-ray; cardiac MRI and/or CT scan; electrocardiogram (ECG or EKG); echocardiogram; and stress test.
Do I have a Case?
Call The Yost Legal Group at 1-800-YOST-LAW for a free, individual consultation. Currently, The Yost Legal Group is investigating claims that Onglyza and Kombiglyze XR caused diabetics to develop heart failure in all 50 states. We will investigate to determine if you or a loved one has been a victim of a defective diabetes medication. Our team of experienced Onglyza lawyers and Kombiglyze XR lawyers are here to answer your questions. Call The Yost Legal Group at 1-800-YOST-LAW for a free, confidential consultation. There is no fee or expense unless you recover.