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Byetta, generically known as exenatide, is a newer Type II diabetes drug that, in its basic form, is injected twice per day to control blood sugar levels. Part of a class of incretin mimetics, the drug mirrors the behavior of hormones found in the gastrointestinal tract, like GIP and GLP-1, to stimulate insulin secretion and lower blood glucose levels. After its approval in 2005, the FDA signed off on a long-acting version, called Bydureon, in 2012.

Yet, since Byetta came onto the market, the FDA has received several adverse reports related to pancreatic and kidney functioning. As a result, multiple patients have come forward to file lawsuits against manufacturers Amylin Pharmaceuticals and Eli Lilly & Co.

Background

From 2005 to 2009, the FDA received multiple reports about patients experiencing kidney or pancreatic conditions after starting Byetta:

  • 78 reports of kidney failure: 91 percent out of this group had to be hospitalized, 18 required dialysis, two needed transplants, and four died. Patients’ symptoms went away after stopping Byetta.
  • 62 reports of renal failure
  • 70 reports of acute pancreatitis, in addition to reports of pancreatic cancer. Out of this group, 21 required hospitalization and six resulted in death.
  • Reports of thyroid cancer

By 2007, the manufacturer decided to update its warning label to include acute pancreatitis as a potential side effect. Yet, this wasn’t enough: A year later, the FDA sent out a report to healthcare providers, mentioning six additional cases of necrotizing pancreatitis or hemorrhagic pancreatitis, with two resulting in death.

By 2009, the FDA required the manufacturers to revise the drug’s warning label. Specifically, it would include information about kidney functioning and renal failure.

Two years later, a study published in Gastroenterology found that patients taking Byetta saw their risk of developing pancreatitis increase six fold, in comparison to a control group not on the diabetes drug. Further, researchers analyzing FDA data from 2004 to 2009 found that those taking the drug also experienced their risk of pancreatic cancer increase three times, and their risk of developing thyroid cancer increase four times.

A 2013 article in JAMA Internal Medicine supported these findings. By examining 1,200 patients hospitalized for pancreatitis, 87 with a prescription for Byetta or a similar drug like Januvia, and comparing them to a control group, researchers discovered that taking these incretin mimetics doubled a patient’s risk of developing pancreatitis, a condition potentially leading to pancreatic cancer.

Additionally, more reports of thyroid cancer related to Byetta started surfacing around 2010. Because studies haven’t been conducted regarding this condition, however, the FDA asked Eli Lilly to do further research in this area.

Lawsuits

As a result of the FDA’s communications, patients started coming forward to file lawsuits against both manufacturers. As of 2016, over 750 lawsuits concerning Byetta and other incretin mimetics have been consolidated into multi-district litigation (MDL) in the Southern District of California.

In these cases, plaintiffs allege Amylin Pharmaceuticals and Eli Lilly & Co. didn’t warn doctors sufficiently about all risks and further continued to market the medications while knowing they were dangerous. Additionally, neither warned about potentially developing pancreatic cancer and pancreatitis, plaintiffs allege, and didn’t issue a recall, even after multiple FDA reports.