For more than a year now, our firm has been entrenched in litigation against the manufacturers of several "incretin mimetic" diabetes drugs, including Januvia, Janumet, Victoza, Byetta, and Onglyza, which, we allege, cause pancreatic cancer.
No trials have been held, and so much of what has occurred there remains confidential, but two recent developments may fundamentally alter the course of the lawsuits - and may help protect unwary patients from one of the most feared diseases known to man.
The drug companies still vehemently deny any connection between these drugs and pancreatic cancer. Their drugs mention all kinds of nuisance side effects, like flatulence and burping, but not one has a word about pancreatic cancer. That may be about to change.
First, in a study published in October 2014, one of the FDA's own labs confirmed that giving a GLP-1 agonist to mice causes precancerous injuries to the pancreas, particularly if the mice eat a high fat, high carbohydrate diet. ("Extended Exenatide Administration Enhances Lipid Metabolism and Exacerbates Pancreatic Injury in Mice on a High Fat, High Carbohydrate Diet.")
In people with type 2 diabetes, the beta cells in the endocrine pancreas don't work as well as they should, and the incretin diabetes drugs are supposed to work by making the beta cells in the endocrine pancreas function better. For example, the incretin diabetes drugs could cause more beta cells to proliferate, or could cause them to grow bigger, or live longer.
Problem is, you can't pick and choose which cells you make proliferate, and at some point, when cells proliferate too much, they become cancerous. Pancreatic cancer is, in many ways, just too many cells growing, and growing too quickly, in the duct of the pancreas.
Technically, the FDA researchers found injuries to the pancreatic ducts consistent with "focal proliferation of the exocrine pancreas and possibly pre-neoplastic PanIn lesion development." That is, they saw the drug - specifically, Byetta - causing mice to develop more cells in their exocrine pancreas. Worse, those cells were damaged in a lot of worrying ways, damage that could make them become "PanIn lesions," which are precancerous.
As the FDA researchers said, they didn't quite see cancer, their findings were "consistent" with the extremely worrying results reported back in 2013 by a team of researchers that found people treated with Januvia and Byetta had evidence of precancerous changes in their pancreas. ("Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors.") That's a pretty big deal, and the FDA researchers said the next step was to look at mice with genetic mutations that made them better mimic pancreatic cancer in humans.
Second, also in October 2014, Health Canada revealed in a communication to physicians that, "[a]s of July 31, 2014, Health Canada received 13 reports of pancreatic cancer suspected of being associated with all incretin-based therapies." Further, the agency "has initiated an epidemiological study through the Drug Safety and Effectiveness Network (DSEN) to assess the potential association between pancreatic cancer and incretin-based therapies and will continue its ongoing monitoring of this potential safety issue."
The study covers Nesina (alogliptin), Tradjenta (linagliptin), Onglyza (saxagliptin), Januvia / Janumet (sitagliptin), Byetta (exenatide), and Victoza (liraglutide).
We'll see if either action causes some serious change in these products, like perhaps a withdrawal, as Public Citizen has recommended for Victoza, or at least better warnings. Patients have the right - the legal, ethical, and moral rights - to know the risks of the drugs they pay for and put into their bodies.
If you or a loved one developed pancreatic cancer after taking Byetta, Januvia, Janumet, Victoza, or another diabetes drug, please read more about our pancreatic cancer lawsuits.