The type-2 diabetes drug Bydureon (exenatide) has been linked to pancreatitis (inflammation in the pancreas), a risk-factor for pancreatic cancer.
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Bydureon is the extended-release version of Byetta (exenatide). It belongs to a class of drugs known as incretin mimetics, which help lower blood-sugar levels by stimulating the pancreas to release more insulin.
What is the problem?
Because Bydureon relies so heavily on the pancreas, many experts are concerned it could cause low-level inflammation (pancreatitis). Over time, chronic pancreatitis can increase the risk of pancreatic cancer.
People with diabetes are more likely to develop pancreatic cancer, but the reason why is unknown. Many types of pancreatic cancer are aggressive and spread to other organs (metastatize) very quickly. Because the pancreas is located so close to other vital organs, it is very difficult to treat after it has spread.
Hemorrhagic and Necrotizing Pancreatitis
Experts are also concerned about a possible risk of hemorrhagic or necrotizing pancreatitis, which can be deadly. In 2008, the FDA warned that exenatide had been linked to six cases of patients who were hospitalized with severe pancreatitis, including two patients who died.
FDA Safety Warnings for Pancreatic Cancer
In March 2013, the FDA warned that researchers had found evidence of pancreatitis and pre-cancerous growths in patients who took diabetes drugs in the incretin mimetic class, such as Bydureon.
The study found that patients who used exenatide for at least one year had pancreases that were 40% larger than normal due to proliferation of cells. In another study from 2010, researchers found a 2.9-fold increased risk of pancreatic cancer associated with exenatide
Bydureon Settlements Announced
In a quarterly financial report released in August 2014, AstraZeneca announced settlement agreements in 84 lawsuits involving Byetta or Bydureon that were pending in California state court. Terms of the settlements were not disclosed. The company still faces hundreds of lawsuits alleging that the drugs caused users to develop pancreatitis, pancreatic cancer, and thyroid cancer.
What is Pancreatic Cancer?
Pancreatic cancer occurs when cells start growing uncontrollably in the pancreas, which is a digestive organ located behind the stomach. Most pancreatic cancers are exocrine tumors that start in the ducts of the pancreas.
Symptoms of Pancreatic Cancer
Unfortunately, because pancreatic cancer rarely produces symptoms in its early stages, many people are not diagnosed until it is too late to cure. When symptoms do appear, they may include:
- Abdominal pain or discomfort
- Back pain
- Fatigue or weakness
- Jaundice (yellowing of the skin and eyes)
- Loss of appetite and weight-loss
- Nausea, vomiting
- Dark urine or clay-colored stools
- And more
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