The FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and precancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on exam of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.
In response, 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). 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 said 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 information.
The FDA has 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.