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A Chicago woman has filed a new Onglyza lawsuit, claiming manufacturer AstraZeneca is liable for her mother’s death.

The case was filed on October 29, 2015, in the Cook County Circuit Court. The plaintiff seeks in excess of $50,000 in damages.

Plaintiff Claims AstraZeneca Failed to Warn About Onglyza Risks

The FDA approved Onglyza (saxagliptin) in July 2009 for the treatment of type 2 diabetes. The drug belongs to a class of medications called “dipeptidyl peptidase-4 (DDP-4) inhibitors,” or “incretin mimetics.” These drugs help lower blood glucose levels by stimulating the pancreas to make more insulin after a meal. That insulin is then used to process the additional glucose.

In early 2014, the FDA released a drug safety communication alerting patients and health care providers that they had requested additional clinical trial data from AstraZeneca. They were looking into the possibility that the drug may be associated with an increased risk for heart failure.

After further analysis, the FDA reported that study results showed that people taking Onglyza had a 27 percent increased risk of hospitalization for heart failure. The plaintiff in this new case says that her mother started taking Onglyza in 2010 for the treatment of her type 2 diabetes. She was then diagnosed with heart failure in June 2011. In 2013, she was hospitalized twice, and passed away in October 2013.

The plaintiff claims that AstraZeneca failed to adequately warn patients about the increased risk of heart failure when taking Onglyza.

Onglyza Linked to Risk of Heart Failure and Pancreatitis

In October 2015, at around the same time as the filing of this lawsuit, the FDA denied an application by AstraZeneca for a new diabetes drug combining Onglyza with Farxiga (dapagliflozin), another type 2 diabetes drug. According to Reuters, the FDA sent a letter to AstraZeneca, stating that it needed more clinical data before such a drug could be approved.

Meanwhile, Onglyza continues to have strong sales, earning $709 million in 2012, and $391 in just the first half of 2015. Despite the drugs strong sales record, Onglyza is now the subject of concern, not only because of the potential link to heart failure, but because of studies linking its use to an increased risk of pancreatitis.

In March 2013, the FDA released another safety communication announcing its investigation into incretin memetic drugs and pancreatitis. In addition to Onglyza, Januvia, Byetta, and Nesina were suspected as potentially increasing the risk of unhealthy changes in the pancreas.

In 2013, researchers looked at this class of drugs, and found that patients with type 2 diabetes who took these drugs had an increased risk of enlarged pancreas and precancerous cellular changes in the pancreas, which could potentially lead to cancer.

One Comment

  1. Gravatar for Anthony Williamson
    Anthony Williamson

    My wife developed pancreatic cancer and passed in 2014 after being prescribed onglyza.DON'T TAKE IT

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