In a just-released U.S. Food and Drug Administration (FDA) Drug Safety Communication, the agency said it is investigating reports of possible increased risk of pancreatitis and pre-cancerous findings in some Type 2 diabetes drugs.
Incretin mimetic drugs imitate the body’s incretin hormones. These hormones are meant to stimulate insulin release following consumption of meals and are used in collaboration with diet and exercise to lower blood sugar in adults diagnosed with Type 2 diabetes.
Incretin mimetic drugs include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin).
These drugs have been the subject of research, including unpublished new findings being evaluated by the FDA. This emerging research was conducted by a group of academic researchers whose findings suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes—pancreatic duct metaplasia—in Type 2 diabetic patients treated with incretin mimetics.
In 2009, the agency required a label update warning of the risk of acute pancreatitis, a painful, potentially fatal disorder and a known risk factor for pancreatic cancer.
The study’s findings were based on a review of a small number of pancreatic tissue specimens that were taken from patients who had died from a number of causes. The FDA has since asked the research team to provide the methodology it used to collect and study these specimens and the tissue samples it utilized. The FDA intends to continue investigating potential pancreatic toxicity associated with incretin mimetics.
Although the FDA said it has not reached any new conclusions about the safety risks associated incretin mimetics, the agency informed the public and the health care community that it intends to secure and evaluate the new information that reveals links between these Type 2 mediations and increased risks for pancreatic diseases, including cancer of the pancreas.
In a notice on its website, the FDA indicated that this is the first time it has communicated a possible pre-cancerous link to incretin mimetics, said Reuters.