Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) are part of a class of drugs known as DPP-4 inhibitors, which are also known as incretin-based therapies. Other diabetes medications in this same drug class include Januvia (sitagliptin), Nesina (alogliptin), and Tradjenta (linagliptin).

Onglyza and Kombiglyze are designed to help patients with type 2 diabetes control their blood sugar levels. The drugs work by helping the pancreas secrete higher amounts of insulin, and by stopping the liver from creating excess levels of sugar.

These two drugs are sometimes prescribed in combination with other medications, or in the form of drugs such as Qtern, which combines combine saxagliptin with other medications.

Researchers Uncover Increased Heart Failure Risk with Onglyza & Kombiglyze

In 2013, AstraZeneca completed a 16,000-patient study of saxagliptin (the active ingredient in Onglyza) called SAVOR. The results of that trial were published in the New England Journal of Medicine and raised major concerns about the cardiovascular safety of Onglyza. 

In 2016, the Food and Drug Administration warned that patients taking Onglyza or Kombiglyze may face an increased risk of heart failure. The FDA warning was based on the results of a study that found that patients taking these drugs were more likely to be hospitalized for heart failure. The study found that patients taking drugs containing saxagliptin (including Onglyza and Kombiglyze XR) were 25% more likely to suffer heart failure than patients taking a placebo. 

Based on the results of this study, the FDA ordered the manufacturers of Onglyza or Kombiglyze to add a warning about the risk of heart failure to the drugs’ labeling. This warning notes that the increased heart failure risk associated with the diabetes drugs was especially pronounced in patients with pre-existing heart disease or kidney disease.

FDA Warns of Potential Cancer Risk

In 2013, the FDA launched an investigation into a possible increased risk of pancreatitis and pancreatic cancer in patients taking Onglyza, Kombiglyze, or other incretin-based therapies. The FDA’s warning was issued after tissue samples taken from patients who had been treated with  incretin-based therapies revealed pre-cancerous cellular changes known as pancreatic duct metaplasia.

The FDA had previously warned in 2011 about the increased risk of pancreatitis associated with incretin-based therapies such as Onglyza and Kombiglyze. Pancreatitis can often be a precursor to pancreatic cancer, which is one of the deadliest forms of cancer because it ofter goes undetected until the disease is in its advanced stages.

Contact Us for a Free Legal Consultation

If you or a loved one were diagnosed with heart failure or cancer after using Onglyza and Kombiglyze XR, you may be eligible to file a lawsuit against the manufacturers of these drugs. The first step in taking legal action is to consult with an experienced pharmaceutical liability attorney, who can guide you through the first steps in filing a claim.

The lawyers at Hissey Mulderig & Friend have filed thousands of lawsuits on behalf of clients who were injured by dangerous drugs, defective medical devices, or other products. Our attorneys have achieved millions in settlements on behalf of our clients.

To learn more about filing an Onglyza or Kombiglyze lawsuit, contact the lawyers at Hissey Mulderig & Friend for a free legal consultation. You can reach us by calling toll-free at 1-866-806-8117, or by filling out the free case evaluation form located on the right side of this page.