Incretin Memetic Drugs
March 20, 2013
FDA is informing health professionals and the public of a possible increased risk of pancreatitis and pancreatic duct metaplasia in patients using incretin memetic drugs for type 2 diabetes. This drug class includes alogliptin (Kazano, Nesina, Oseni), exenatide (Bydureon, Byetta), linagliptin (Jentadueto, Tradjenta), liraglutide (Victoza), saxagliptin (Kombiglyze XR, Onglyza), and sitagliptin (Janumet, Janumet XR, Januvia, Juvisync). Researchers found abnormal cells in pancreatic tissue specimens of deceased patients previously taking incretin memetics who died from unknown causes. Incretin mimetics currently carry a warning for an increased risk of acute pancreatitis. It is unknown at this time if this class of drugs poses an increased risk of pancreatic cancer, but FDA is conducting ongoing safety analysis.
FDA has not finalized their assessment of these recent findings and will communicate recommendations once the evidence has been evaluated. FDA will attend a workshop in June 2013 sponsored by the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) and the National Cancer Institute (NCI) to discuss this topic. Patients are encouraged to continue to take their medications as prescribed. Patients should discuss their questions and concerns with their healthcare provider. Healthcare professionals should continue to follow the recommendations in the drug labeling when prescribing incretin memetics.
FDA encourages patients and healthcare professionals to report adverse reactions to FDA’s MedWatch Program at www.fda.gov/medwatch.
- MedWatch Alert:
- Drug Safety Communication:
March 20, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.