Onglyza, a Type 2 diabetes drug that belongs to a class of medications called incretin mimetics, may be associated with a number of serious complications, including heart failure, pancreatitis and pancreatic cancer. These concerns have prompted the U.S. Food & Drug Administration (FDA) to issue several safety alerts for incretin mimetic medications, including Onglyza. If you developed any of these conditions while taking this drug, you may be eligible to file an Onglyza lawsuit to obtain compensation for your medical bills, lost wages, pain and suffering, and other damages.
The attorneys at Bernstein Liebhard LLP are investigating the possible association between Onglyza and heart failure, as well as the drug’s potential to cause pancreatitis or pancreatic cancer. If you believe you or a loved one were harmed by Onglyza or a related medication sold under the brand name Kombiglyze XR, we urge you to contact one of our attorneys today to learn more about your legal options.
Onglyza and Heart Failure
Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCl extended-release) are intended to be used in conjunction with diet and exercise to control Type 2 diabetes in people who do not suffer from diabetic ketoacidosis. Both allow the pancreas to secrete more insulin and stop the liver from making excess sugar.
In October 2013, a study published in the British Medical Journal suggested that saxagliptin was associated with a 27% increased risk of hospitalization for heart failure. The following February, the FDA announced that it was investigating a possible association between saxagliptin and heart failure, and had requested raw data from that study, known as the SAVOR-TIMI 53 trial.
The SAVOR-TIMI 53 trial involved 16,492 diabetics who were randomly assigned Onglyza or a placebo, all of whom had a history of heart disease or had other risk-factors. The study followed patients for a median of 2.5 years, and indicated that 3.5% of those treated with Onglyza were hospitalized with heart failure, versus 2.8% of placebo patients.
In April 2015, the FDA convened an advisory panel meeting to further investigate the potential for Onglyza to cause heart failure. The panel voted 14-to-1 to recommend that the labels for Onglyza and Kombiglyze XR be modified to include new information about a possible association with heart failure and death. While the FDA is not obligated to follow the recommendations of its advisory panels, it usually does so.
Onglyza and Pancreatic Cancer, Pancreatitis
In recent years, evidence has been mounting that links incretin mimetics like Onglyza to an increased risk of pancreatitis and pancreatic cancer. In March 2013, a study published in the medical journal Diabetes found evidence of increased pancreatic mass and precancerous cellular changes in the pancreatic tissue of people who had used incretin mimetics. The publication of that study prompted the FDA to begin reviewing the possibility of an association between Onglyza and pancreatic cancer.
The FDA has also received postmarketing reports of acute pancreatitis in people taking Onglyza, and advises that patients should be observed carefully for signs and symptoms of pancreatitis. Healthcare providers have been advised to stop treatment in patients who they suspect may have developed Onglyza pancreatitis.
Learn More about Filing an Onglyza Lawsuit
Bernstein Liebhard LLP is offering free, no-obligation case reviews to individuals who may have been harmed by Onglyza or Kombiglyze XR. If you are interested in pursuing an Onglyza lawsuit for heart failure, pancreatitis or pancreatic cancer, please call 1-877-779-1414 to discuss your case with a member of our legal staff.