The FDA is evaluating an increased risk for pancreatitis and precancerous cellular changes called pancreatic-duct metaplasia associated with incretin mimetic drugs used to treat patients with type 2 diabetes.
This evaluation is based on unpublished new findings by a team of academic researchers who examined a small number of pancreatic-tissue specimens taken from patients after they died from unspecified causes. The FDA requested that the academic researchers provide the methodology used to collect and study these specimens and to provide tissue samples for further investigations regarding this potential pancreatic toxicity associated with incretin mimetics.
The incretin mimetic class includes exenatide (Byetta, Bydureon; Amylin and Lilly), liraglutide (Victoza; Novo Nordisk), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync; Merck), saxagliptin (Onglyza, Kombiglyze XR; Bristol-Myers Squibb), alogliptin (Nesina, Kazano, Oseni; Takeda), and linagliptin (Tradjenta, Jentadueto; Boehringer Ingelheim and Lilly). Incretin mimetics 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 in conjunction with diet and exercise to lower blood sugar in adults with type 2 diabetes.
At this time the FDA has not reached any conclusions about safety risks with incretin mimetic drugs. The communication is only intended to inform the public and health care professionals that the FDA intends to obtain and evaluate this new information. The FDA stresses that patients should continue to take their medicine as directed until they talk to their healthcare provider and healthcare providers should continue to follow the prescribing recommendations in the drug labels.
Previously, on August 19, 2008, and September 25, 2009 the FDA had warned the public about the postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of incretin mimetic drugs exenatide and sitagliptin.
For more information visit http://www.fda.gov/Drugs/DrugSafety/ucm343187.htm.