The US Food and Drug Administration (FDA) is evaluating an increased risk for pancreatitis and precancerous cellular changes called pancreatic-duct metaplasia associated with incretin mimetic drugs used to treat patients with type 2 diabetes. This covers the glucagon-like peptide-1 (GLP-1) agonists and the DPP-4 inhibitors, both relatively new classes of agent used to treat adults with type 2 diabetes. A group of researchers came up with a study showing that there is a link between incretin mimetics and pancreatic cancer.
In the unpublished study, researchers examined a small number of pancreatic tissue specimens taken from patients after they died from unspecific cause. FDA requested the researchers to provide the methodology of the study as well as the tissue samples for further investigation.
Incretin mimetic drugs work by mimicking the incretin hormones that are naturally produced to stimulate secretion of insulin in response to a meal. It was known that these agents might increase risk of acute pancreatitis.
This is the first time FDA has issued a communication with regard to the potential risk for precancerous findings of the pancreas with incretin mimetics. It emphasizes, however, that it "has not concluded these drugs may cause or contribute to the development of pancreatic cancer."
According to study leader Dr. Sonal Singh, M.D., M.P.H., an assistant professor in the Division of General Internal Medicine at the John Hopkins University School of Medicine, "These agents are used by millions of Americans with diabetes. These new diabetes drugs are very effective in lowering blood glucose. However, important safety findings may not have been fully explored and some side effects such as acute pancreatitis didn't appear until widespread use after approval." FDA recommends patients to keep taking the prescribing drugs until further notice.
FDA notes that it "has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and healthcare professionals that the agency intends to obtain and evaluate this new information."
FDA says it is continuing to evaluate all available data to further understand this potential safety issue and will participate in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013 to gather and share additional information.
FDA will communicate its final conclusions and recommendations when its review is complete or when the agency has additional information to report.
More Information available on the FDA website.