Link Between Byetta, Januvia and Pancreatic Damage Confirmed by Study

Italian researchers have published a study that adds to the recent concerns about the side effects of diabetes drugs like Byetta, Januvia, Janumet and Victoza, which have been linked to a potential risk of damage to the pancreas and pancreatic cancer.  

In a study published earlier this month in the medical journal Expert Opinion on Drug Safety, researchers from Ferrara, Italy, say they have confirmed U.S. studies linking a class of diabetes drugs known as incretin mimetics to pancreatic damage.

Researchers looked at 1,169 adverse drug reaction reports that concerned incretin mimetics, which is a relatively new class of diabetes medications that includes Byetta, Victoza, Januvia and Janumet. They found 90 instances of pancreatitis and elevated pancreatic enzymes, with more than a third of those cases serious. This raises concerns that cases of chronic pancreatitis may lead to the development pancreatic cancer among some users.

“Our data from the daily clinical practice add up and confirm the information available on the association between incretin-mimetics and pancreatic damage and suggest caution in the prescribing of these new drugs and a close monitoring of exposed patients,” the researchers concluded.

The findings support prior research that has identified a link between drugs like Januvia and pancreatitis. In February, researchers from Johns Hopkins in Baltimore found that taking Januvia or Byetta may double the risk of hospitalization due to pancreatitis, which raised concerns about whether this may also suggest an increased risk of pancreatic cancer.

In March, the risk of pancreatic cancer from Januvia, Byetta and other incretin mimetics gained additional attention after another study published in the medical journal Diabetes found that pancreas tissue from organ donars found that those who took an incretin mimetic were more likely to have increased pancreatic mass and precancerous cells, which are cells with the potential to evolve into tumors.

Shortly after receiving the preliminary findings the FDA launched an investigation into Januvia and Byetta pancreatic cancer risks. Although the agency has indicated that current data does not show any evidence of a heightened risk, questions have continued in connection with the drugs.

Pancreatic Cancer Litigation

Dozens of former incretin mimetic users who have been diagnosed with pancreatic cancer are currently pursuing product liability lawsuits against the makers of the drugs alleging that makers failed to adequately research the medications or provide sufficient warnings for users and the medical community about the risk of pancreatic damage.

In August, the U.S. Judicial Panel on Multidistrict Litigation established consolidated pretrial proceedings for all Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits involving plaintiffs diagnosed with pancreatic cancer.

There are currently more than 150 cases centralized before U.S. District Judge Anthony J. Battaglia in the Southern District of California to reduce duplicative discovery across a large number of cases, to avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

Byetta (exenatide) was the first member of the incretin mimetic class approved by the FDA, introduced by Amylin Pharmaceuticals in 2005 as a twice daily injection. Januvia (sitagliptin) was introduced by Merck the following year as an oral medication, and a combination pill containing Januvia and the older diabetes medication metformin was introduced in 2007 under the brand name Janumet. Victoza (liraglutide) was introduced by Novo Nordisk in 2010 as a daily injection.

As Byetta and Januvia lawyers continue to review and file additional cases in the coming months and years, it is ultimately expected that there could be a few thousand lawsuits centralized in the federal litigation.