FDA Launches New Evalution into Link Between Type 2 Diabetes Meds and Pancreatitis

Washington, DCSeveral recently approved diabetes medications, including Januvia and Janumet (Merck), Victoza (Novo Nordisk) and Byetta and Bydureon (Bristol-Myers Squibb), have come under new review by the Food and Drug Administration (FDA), as a result of emerging evidence which suggests these drugs increase the risk for pancreatitis.

In a statement released earlier this week, the FDA said they are “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics."

The FDA noted that these findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. The agency has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so they 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). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

The FDA previously warned the public about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of the incretin mimetic drugs exenatide and sitagliptin.

A recently published study that examined insurance records also found the use of exenatide or sitagliptin could double the risk of developing acute pancreatitis. The Warnings and Precautions section of the drug labels and the patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. The FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics. Further, the FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer.