March 27, 2013
FDA Evaluates Precancerous Pancreatic Risks
With Incretin Mimetics

Washington, D.C.—The FDA is evaluating new, unpublished information suggesting an increased risk of pancreatitis and precancerous cellular changes in patients with type 2 diabetes treated with incretin mimetics.

So far, FDA has not reached any conclusions on the risks or made any changes in recommended use of the drugs.

The new information is based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes, according to the FDA. Researchers have been asked to share the methodology used to collect and study the specimens and also to provide the tissue samples to public health officials for investigation.

Drugs in the incretin mimetic class include exenatide, (marketed as Byetta and Bydureon); liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).

Approved to lower blood sugar in adults with type 2 diabetes along with diet and exercise, the drugs work by mimicking the incretin hormones usually produced naturally in response to a meal to stimulate the release of insulin.

Warnings about the risk of acute pancreatitis already are included in the warnings and precautions section of incretin mimetics drug labels and patient medication guides, but FDA has not previously communicated about the potential risk of precancerous findings of the pancreas. As of now, no conclusions have been reached on whether the drugs cause or contribute to the development of pancreatic cancer, according to the FDA.

More information should be available in June when FDA participates in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute’s (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer. FDA also said it will announce any recommendations and/or final conclusions when the current review is complete or when additional information is available.

Meanwhile, pharmacists and other health care professionals should urge patients on incretin mimetics to continue to take their medications as directed, unless the prescriber makes a change, according to the FDA, which said current prescribing recommendations on drug labels should be followed.

U.S. Pharmacist Social Connect