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Regulatory Focus™ > News Articles > Class of Diabetes Drugs Associated With Pancreatitis and Cancer, Says FDA

Class of Diabetes Drugs Associated With Pancreatitis and Cancer, Says FDA

Posted 15 March 2013 | By Alexander Gaffney, RAC

A safety warning released on 14 March 2013 by the US Food and Drug Administration (FDA) states that regulators have become aware of and are investigating reports that incretin mimetic drugs for type-2 diabetes could possibly increase a patient's risk of developing pancreatitis and cancer.

The drugs-which include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto)-mimic the body's natural hormones to regulate the release of insulin and control type-2 diabetes.

Based on what FDA called an "examination of a small number of pancreatic tissue specimens taken from patients after they died," it said it is concerned about "potential pancreatic toxicity" associated with the drugs.

FDA has been aware for years of a loose association between two of the drugs , exenatide and sitagliptin, and acute pancreatitis. The new reports both expand the number of drugs potentially associated with the risks and notes the potential risk of developing cancer as well.

These associations are not yet conclusive, FDA added. Accordingly, the agency said it intends to study the issue in further depth and participate in a June 2013 meeting being run by the National Cancer Institute (NCI) on the association between pancreatitis, diabetes and pancreatic cancer.

Pancreatitis is a severe condition marked by inflammation of the pancreas that requires immediate medical treatment. 


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