New Study Suggests Certain Type 2 Diabetes Drugs May Cause Pre-Cancerous Pancreatic Cell Growth

An article published by Bloomberg indicates that new research suggests that popular diabetic drugs like Januvia®, which is manufactured by pharmaceutical giant Merck & Co., may promote pre-cancerous pancreatic cell changes and proliferation. The new report from UCLA researchers follows an FDA statement earlier this month indicating that the federal agency was reviewing unpublished findings suggesting that abnormal pre-cancerous cell changes may be linked to a category of Type 2 diabetes drugs referred to as incretin mimetics, which includes Bristol-Myers Squibb Co. (BMY)’s Byetta®.

There has been concern among physicians about this type of Type 2 Diabetes drug since the FDA issued a report in 2007 that disclosed an elevated number of cases of pancreatitis among patients taking Byetta. This alert was extended to Januvia® in 2009. These warnings amplify concerns expressed in an article published in the JAMA Internal Medicine journal last month that were based on a review of insurance records and suggested this class of drugs may double the risk of pancreatitis.

In the recently released study, researchers examined the pancreases of twenty diabetics and found that among the eight receiving incretin drugs there was a forty percent increase in pancreatic cells and damaged cells according to the journal Diabetes. Eight of the patients were receiving incretin mimetics drugs with seven being treated with Merck’s Januvia® and one taking Byetta®. According to the researchers, those receiving incretin drugs exhibited “marked” proliferation of cells and cellular damage that could develop into cancer.

Merck declined to comment on the findings of the report but indicated that “an extensive nonclinical safety program” involving Byetta® did not reveal “any drug-related pancreatic tissue damage or toxicity in any species tested.”

The FDA received approximately 88 adverse event reports between October 2006 and February 2009 involving acute pancreatitis by patients taking Januvia® and Janumet®, which combines melformin and Januvia®. Some of the facts disclosed by the FDA about these adverse reports include:

• Two-thirds of the cases resulted in hospitalization.
• One in five of the patients developed pancreatitis within a month of beginning use of one of these two drugs.
• More than half of the patients’ medical conditions resolved after they discontinued use of the drugs.
• Two of the cases involved severe hemorrhagic or necrotizing pancreatitis.

Generally, a drug manufacturer may be liable for a defective pharmaceutical based on faulty design, improper manufacturing or inadequate warnings of risks associated with the drug. The FDA has not imposed labeling requirements but will presumably continue to analyze adverse event reports associated with the diabetes drug.

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