Incretin mimetics' effects on pancreas under investigation

The FDA is investigating reports of possible increased risk of pancreatitis and precancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.

The investigation is based on unpublished new findings based on examination of a small number of pancreatic tissue specimens taken from patients after they died of unspecified causes. The FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the agency can further investigate potential pancreatic toxicity associated with the incretin mimetics. Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).

The FDA has not reached any new conclusions about safety risks with incretin mimetic drugs and will communicate its final conclusions and recommendations when the review is complete or when additional information is available to report.