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New Report Further Boosts Notion of Link Between Incretin Mimetics and Pancreatitis

Filed November 25th, 2013 edlieber1

A November 13 article posted on Informa Healthcare provides information that further links incretin mimetic drugs – including Bydureon, Byetta, Janumet, Januvia, Jentadueto, Kombiglyze XR, Nesina, Onglyza, Tradjenta, and Victoza – to pancreatitis.

Incretin mimetics are used to treat Type 2 diabetes. They work by mimicking hormones that increase the release of insulin. By analyzing adverse drug reaction (ADR) reports, researchers in Italy previously confirmed a link between these drugs and pancreatic injuries, according to AdverseEvents.com.

The U.S. Food and Drug Administration (FDA) posted a Drug Safety Communication on its website in March that stated the agency was looking into 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 take action in response to the connection between the drug and the pancreatitis,  AdverseEvents.com reported.

The authors of the study analyzed data from the Italian Spontaneous ADR Reporting Database to identify relevant cases related to incretin mimetics. They examined over 1,500 reports, including 90 cases of pancreatitis or elevated levels of pancreatic enzymes.]

The researchers concluded that the data showed a link between the drugs and pancreatic impairment and said that patients taking the medications should be monitored for potential harm, according to AdverseEvents.com.

Using FAERS data (from 11/01/1997 to 12/31/2012), aggregated and standardized by the AdverseEvent RxFilter process, the study’s authors identified 4,512 reports of pancreatitis and 14 cases of elevated pancreatic enzyme levels in which incretin mimetics were listed as the suspected cause. Of these cases, 2,478 hospitalizations and 113 patient deaths were suspected to have resulted from incretin mimetics, AdverseEvents.com reported.

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