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By: Austin Kirk | Published: March 25th, 2013
The findings of new research have identified precancerous changes in the pancreas of diabetes patients who used a class of diabetes drugs known as incretin mimetics, which include Byetta, Januvia, and Victoza, raising serious concerns about the potential risk of pancreatic cancer that may be associated with the medications.
The study was released late last week, ahead of print in the medical journal Diabetes. However, the findings were already highlighted by the FDA earlier this month, when the agency indicated that it was investigating the potential risk of pancreatic cancer with Byetta, Januvia, Victoza and other similar diabetes drugs.
Researchers examined pancreata from organ donors with type 2 diabetes, finding that those who took drugs like Byetta and Januvia were more likely to have increased pancreatic mass and precancerous cells, which are cells with the potential to evolve into tumors.
After receiving the unpublished findings, the FDA issued a drug safety communication on March 14, indicating that it was examining the risk of pancreatitis and pancreas cancer. The agency asked the researchers for further information on the methodology used to collect and study these specimens, as well as for tissue samples so the agency may further investigate the potential pancreatic toxicity with Byetta, Januvia and Victoza.
Concerns about the risk of pancreatic cancer and pancreatitis from Byetta and Januvia was heightened last month by a study published in JAMA Internal Medicine. The study suggested that taking the medications may double the risk of hospitalization due to pancreatitis and researchers expressed concern that this may ultimately caused some users to develop pancreatic cancer, since chronic pancreatitis is a known risk factor for the development of pancreatic cancer.
The consumer watchdog group Public Citizen issued a press release on March 22, heralding the researchers’ findings. Public Citizen has already petitioned the FDA for a Victoza recall due to pancreas side effects and a risk of thyroid cancer. The group has already criticized the entire class of drugs for providing minimal, if any, actual benefits for diabetics.
“It is clear that all of the drugs in this family are associated with an increased risk of pancreatic cancer and it is likely that they will all have to be removed from the market,” the Public Citizen press release states. “The idea of putting a warning label about pancreatic cancer on drugs that have no unique benefit for diabetics but which have increasing evidence of the risk for pancreatic cancer — instead of banning the drugs altogether — would be an extraordinarily reckless approach for the FDA to initiate.”
A number of former users of the diabetes drugs who have been diagnosed with pancreatic cancer are already pursuing Byetta lawsuits, Januvia lawsuits and Victoza lawsuits, alleging that the drug manufacturers have ignored information about the potential toxicity to the pancreas and failed to warn about the potential pancreatic cancer side effects.