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New Italian Research Bolsters Association of Diabetes Drugs with Pancreatitis

Nov 26, 2013

Informa Healthcare recently published an article online that supports ongoing allegations of a link between incretin mimetic diabetes medications and the development of pancreatitis.

Incretin mimetics—which include Bydureon, Byetta, Janumet, Januvia, Jentadueto, Kombiglyze XR, Nesina, Onglyza, Tradjenta and Victoza—are medications for the treatment of Type 2 diabetes, Drug Safety Monitor reports. They work by mimicking hormones that increase the release of insulin and are used in conjunction with diet and exercise to reduce glucose levels. Italian researchers examined adverse drug reaction reports and confirmed the association between these drugs and pancreatic damage.

In March of 2013, the U.S. Food and Drug Administration (FDA) published a Drug Safety Communication that said the agency was “investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.” The FDA has not yet decided whether to institute regulatory action for these medications.

In March of 2013, the U.S. Food and Drug Administration (FDA) published a Drug Safety Communication that said the agency was “investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.” The FDA has not yet decided whether to institute regulatory action for these medications.

Using the FDA’s Adverse Events Reporting System (FAERS) data from 11/01/1997 to 12/31/2012, Drug Safety Monitor identified 4,512 reports of pancreatitis and 14 cases of elevated pancreatic enzyme levels where incretin mimetics were listed as the primary suspect. Of these cases, Drug Safety Monitor identified 2,478 hospitalizations and 113 patient deaths where incretin mimetics were indicated as the primary suspect.


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