FDA Warning for Pancreatic Cancer in Diabetes Drugs

March 15, 2013 — The U.S. Food and Drug Administration (FDA) has published a Safety Alert to warn that diabetes drugs in the incretin mimetic class (such as Byetta, Januvia, Janumet, and more) may be associated with pancreatic cancer. Although the FDA has not concluded that these drugs cause or contribute to pancreatic cancer, they are evaluating unpublished results of a new study that seems to suggest a possible risk.

The alert was published in response to a study published in February by JAMA Internal Medicine that linked GLP-1 therapy diabetes drugs to a doubled risk of pancreatitis (pancreas inflammation), which is a known risk factor for pancreatic cancer.

The study was conducted by a group of academic researchers who took tissue samples from the pancreas of individuals with type-2 diabetes who took an incretin mimetic medication and died of unspecified causes. The findings suggest an increased risk of pancreatitis and pre-cancerous cells in the pancreas.

The pre-cancerous cellular changes were called pancreatic duct metaplasia by the researchers. A pre-cancerous metaplasia is any abnormal transformation from one tissue type to another. In some cases, it can be a precursor to neoplasia, in which abnormal cells begin proliferating and form abnormal tissue growths. Pancreatic ductal carcinoma is the most common type of pancreatic cancer (75-80% of cases).

The FDA did not make any recommendations regarding safety risks, but they announced that they would participate in a workshop on pancreatic cancer in June 2013:

“This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information.”

Drugs in the incretin mimetic class include:

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