Can Diabetic Medications Increase Pancreatic Cancer Risk?

As a Texas medical doctor and attorney I have expressed alarm at the epidemic of childhood obesity and the onslaught of type 2 diabetes in adult folks living in the US.

What is Diabetes?

Diabetes mellitus, (DM) is a group of metabolic diseases in which a person has high blood sugar, either because the pancreas does not produce enough insulin, or because cells do not respond to the insulin that is produced. Type 2 DM results from insulin resistance, a condition in which cells fail to use insulin properly, sometimes combined with an absolute insulin deficiency. This form of diabetes is the most common form in adults.

Side Effects From Diabetes

Untreated, diabetes can cause many severe complications. Acute complications include diabetic ketoacidosis and nonketotic hyperosmolar coma. Serious long-term complications include cardiovascular disease, chronic renal failure, and diabetic retinopathy (retinal damage). Adequate treatment of diabetes is therefore important, as well as blood pressure control and lifestyle factors such as stopping smoking and maintaining a healthy body weight.

Byetta, Januvia and Victoza Pancreatic Cancer Lawsuits

Plaintiffs are alleging that the drug makers' failure to properly research the side effects of Byetta, Januvia and Victoza or provide adequate warnings about the impact of the medications on the pancreas and failure to warn about the risk of pancreatic cancer.

What is Byetta, Januvia and Victoza?

Byetta (exenatide) is a type 2 diabetes drug which was approved by the FDA in April 2005 to help reduce blood sugar levels.

Januvia (sitagliptin) was approved in October 2006 as the first in a new class of diabetes medications, known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Janumet combines Januvia and Metformin for diabetics who do not gain diabetic control from the single medication.

Victoza (liraglutide) was approved by the FDA in January 2010 for the treatment of type 2 diabetes. Early animal testing showed increased thyroid cancers and when the drug was given to humans in the pre-trial testing stage the rate of thyroid cancer tripled.

Byetta, Januvia and Victoza, as well as several other drugs, belong to a class of drugs known as incretin mimetics, which mimic the action of endogenous incretin hormones like GIP and GLP-1, which are found in the gastrointestinal tract. Byetta Januvia and Victoza lowers blood glucose levels by stimulating insulin secretion from pancreatic cells.

Byetta, Januvia and Victoza Pancreatitis Risk

Shortly after Byetta pen was on the market, reports of pancreatitis began to emerge. In October 2007, the FDA issued an alert after 30 patients using Byetta were diagnosed with acute pancreatitis. In August 2008, FDA increased the warnings after at least six additional cases of necrotizing pancreatitis or hemorrhagic pancreatitis were identified among Byetta users, including at least two deaths

Shortly after Januvia was on the market, the FDA required an update to the medications warning label in September 2009, providing information about the link between Januvia and pancreatitis. In February 2012, the FDA issued a warning letter to Merck over their failure to conduct required testing on the risk of pancreatitis from Januvia and Janumet side effects. Merck promised to conduct a three month study on Januvia’s pancreatic safety by June 2011, but the drug maker never did.

In March 2013, the FDA launched an investigation into the potential link between pancreatic cancer and Januvia, after a study confirmed that use of the medication may double the risk of hospitalization due to pancreatitis.

According to a study published in the medical journal Gastroenterology in February 2011, the development of pancreatic cancer among Byetta users was three times greater than among other diabetics.

In the February 2013 edition of JAMA Internal Medicine, researchers raised serious concerns about the Byetta pancreatic cancer risk, after a study found that individuals treated with Byetta were twice as likely to be hospitalized with pancreatitis, which could ultimately lead to pancreatic cancer.

People given the drug during clinical trials were almost four times as likely to be diagnosed with pancreatitis than patients given other diabetes drugs. After just a year and a half on the market, the FDA received 200 reports of Victoza users being diagnosed with pancreatitis.