Diabetes is one of the most problematic illnesses of our society today. It is not a disease that stands by itself, but those who have it know all too well that the chances of it leading to many other illnesses for them is tremendous. A diabetic is most likely also going to end up with one or more of: heart disease, kidney disease (resulting in dialysis), blindness, and peripheral neuropathy (incapacitating pain in the legs) to name just a few. The studies done on the disease and the medicines to treat it are too numerous to count. And yet, the incidence of this disease is steadily increasing every year. It’s no wonder that there is such a quest to try to get it under control.
The most common type of diabetes is Type 2. With this type, whereas the pancreas used to secrete enough insulin to take care of the sugar eaten, over time it becomes less and less efficient and produces less and less insulin. And the cells become more and more resistant to the insulin it does produce. At some point medication is needed to help the pancreas produce more insulin, and eventually nothing can get it up to producing enough so the body then needs to be given the insulin that it so desperately needs, by way of injection. Type 1 diabetes is usually diagnosed in childhood. In this case, the pancreas is either not producing any insulin, or is producing a dreadfully small amount, and for whatever reason cannot be boosted by medication to produce more, so insulin injections must be started right away.
For many years, the only treatment for Diabetes was either the pills that encouraged the liver to make less sugar (such as Metformin), or the pancreas to make more insulin (such as Glipizide), or the insulin itself. But in the last 10 years or so, several new medications have been introduced to tackle the problem.
One such new medication is Januvia, produced by Merck. Januvia was released in 2007. People – including doctors – were crazy excited about it. Januvia works by increasing the effectiveness of 2 digestive enzymes that help to lower the sugar levels. You can take it either as a pill or an injection and is used only for Type 2 Diabetes.
First Problem on the Radar: Pancreatitis
However, by October of 2009, the FDA had received several reports that patients taking Januvia had developed pancreatitis. Pancreatitis is a very serious and debilitating illness characterized by severe abdominal pain, vomiting, and diarrhea. It is often severe enough to cause hospitalization as the patient cannot keep anything down and needs IV antibiotics and IV fluids for dehydration. It can take weeks to get back to normal and in severe cases, can even lead to death. In these cases, when the patients stopped taking the Januvia, they recovered quickly. But during this time, six people did die from the pancreatitis.
Bigger Problem: Pancreatic Cancer
Studies started being done on this subject to see if there was a correlation between the Januvia and the pancreatitis. In July of 2011, the medical journal Gastroenterology reported that patients taking Januvia had a six times higher risk of coming down with pancreatitis over those not taking Januvia.
This lead to a lot of lawsuits. But they didn’t gain a ton of traction because, frankly, pancreatitis – as awful as it is – was not an injury that got many plaintiff’s lawyers motivated to push the ball forward. But pancreatic cancer is a much different ballgame.
Studies showed that patients on Januvia had a 2.7 times higher risk of developing pancreatic cancer. Other studies that evaluated the pancreas itself of those being treated with incretin (the generic name for Januvia) have shown that there was an inflammation and increase in pancreatic cells, as well as damage to those cells with a potential for those cells, eventually turning into cancer. There is also a similar risk, though to a somewhat lesser amount, with the medications Byetta and Victoza. Byetta has also been found to raise the risk of thyroid cancer.
Dr. Peter Butler of the University of California, Los Angeles, has studied the medical records of many people who have taken Januvia and Byetta and also found an increase in pre-cancerous changes in those Diabetics taking the drugs. Insurance records published in the JAMA Internal Medicine journal in February of 2013 showed that these drugs could double the risk of getting pancreatitis.
Merck is objecting to the studies because they were not “double blind” studies. Okay, so we are not 100% certain. But 2.7 times more pancreatic cancer? It is hard not to be cynical and wonder whether Merck’s view is colored by Januvia worldwide sales in 2012 of 4.1 billion (Byetta’s were about $227 million).
In 2009, a report was released by UCLA that said if Januvia is taken together with Metformin, it cancels out the risk of pancreatitis that is possible when Januvia is taken by itself. However, it is difficult to find any recent reports that confirm this finding. Metformin is one of the oldest Diabetic oral medications and works by controlling how much glucose is produced by the liver. While this is promising, more testing needs to be done on humans before this fact can be relied on as accurate. But because of these preliminary findings, it is currently recommended that if Januvia is going to be taken, it should be taken together with Metformin (trade name Glucophage).
Because of these concerns, there are many doctors who are refusing to order Januvia, Byetta, and Victoza at this point. Should you stop taking Januvia because of these life threatening problems with the drug? We are attorneys, not doctors. What we say is not worth a hill of beans on medicine. Should you be talking to your doctor about these concerns? Absolutely.
If you or someone you care for has developed pancreatic cancer on Januvia or Byetta, call 800-553-8082.