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Bydureon Lawsuit


Bydureon (extended-release exenatide) is a medication that is used to treat type-2 diabetes. Bydureon carries prominent warnings about the risk of thyroid cancer, but there is growing evidence linking exenatide to a possible risk of pancreatitis and pancreatic cancer.

UPDATE: 84 Byetta/Bydureon Lawsuit Settlements Awarded in California

August 20, 2014 — AstraZeneca and Amylin Pharmaceuticals, LLC have agreed to an undisclosed settlement in 84 lawsuits involving Byetta and Bydureon. Approximately 409 lawsuits have been filed by people injured by pancreatitis, pancreatic cancer, and thyroid cancer. Click here to read more.

Multi-District Litigation (MDL) for Pancreatic Cancer Lawsuits

August 2013 — Federal judges have centralized 53 pancreatic cancer lawsuits involving many diabetes drugs into the U.S. District Court for the Southern District of California. The Multi-District Litigation (MDL), which is similar to a class action lawsuit, involves Byetta (exenatide), Januvia (sitagliptin), Janumet (sitagliptin and metformin), and Victoza (liraglutide). The controversy at the heart of the litigation is whether the drugs increase the risk of pancreatic cancer.

What is Bydureon?

Bydureon is a once-weekly injection medication that is used to improve blood-sugar control in people with type-2 diabetes. It is the extended-release version of Byetta (exenatide), which is injected twice-daily. Bydureon is designed to help the pancreas make more insulin, and it does so by mimicking the hormone GLP-1.

Bydureon and Thyroid Cancer

When the U.S. Food and Drug Administration (FDA) approved Bydureon in January 2012, they required the following Black Box warning about a possible risk of thyroid cancer:

“Exenatide extended-release causes thyroid C-cell tumors at clinically relevant exposures in rats. It is unknown whether Bydureon causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.”

Bydureon and Pancreatic Cancer

In March 2013, the FDA published this Drug Safety Communication after reviewing research linking exenatide to an increased risk of pancreatitis, inflammation in the pancreas, and possibly pancreatic cancer.

The research, published in the journal Diabetes in March 2013, examined pancreases of diabetics who took drugs in the incretin mimetic class (such as exenatide) for at least one year. The pancreases were 40% larger than normal due to cell proliferation, and half of the pancreases had pre-cancerous growths — microadenomas and a neuroendocrine tumor.

Another study, published in Gastroenterology in 2010, found that exenatide was associated with a 2.9-fold increased risk of pancreatic cancer. Researchers also linked exenatide to an increased risk of pancreatitis, which is a risk-factor for pancreatic cancer.

Bydureon Side Effects

  • Pancreatitis
  • Pancreatic inflammation
  • Hemorrhagic pancreatitis
  • Necrotizing pancreatitis
  • Pancreatic cancer
  • Thyroid cancer
  • Medullary thyroid carcinoma

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