On November 13, 2013, Informa Healthcare published an article online that gave further support for the connection between incretin mimetic medications and development of pancreatitis. Incretin mimetics (Bydureon, Byetta, Janumet, Januvia, Jentadueto, Kombiglyze XR, Nesina, Onglyza, Tradjenta, Victoza) are medications indicated for the treatment of type 2 diabetes, and they work by mimicking hormones that increase the release of insulin. By examining adverse drug reaction (ADR) reports, Italian researchers confirmed the association between these drugs and pancreatic damage.
In March of 2013, the United States Food and Drug Administration (FDA) posted a Drug Safety Communication that stated 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 yet to come to a conclusion on whether or not to institute regulatory action regarding these medications.
The current study analyzed data from the Italian Spontaneous ADR Reporting Database to identify relevant cases of ADRs related to incretin mimetics. Researchers examined 1,169 reports related to incretin mimetics, which included 90 cases of pancreatitis or elevated levels of pancreatic enzymes. Authors concluded that the data demonstrated the association between this class of drugs and pancreatic impairment, and that patients taking these drugs should be monitored for such potential harm.
Incretin mimetics (Bydureon, Byetta, Janumet, Januvia, Jentadueto, Kombiglyze XR, Nesina, Onglyza, Tradjenta, Victoza) are a class of drugs indicated for the treatment of type 2 diabetes. They work by imitating incretin hormones, resulting in the production of insulin. These drugs are to be used in conjunction with diet and exercise to reduce glucose levels in patients with type 2 diabetes.
Using FAERS data (from 11/01/1997 to 12/31/2012), aggregated and standardized by the AdverseEvent RxFilter process, we 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, we identified 2,478 hospitalizations and 113 patient deaths where incretin mimetics were indicated as the primary suspect.
Note: This analysis does not take into account the number of patients taking each medication. In order to calculate the total number of patients experiencing pancreatitis or elevated pancreatic enzyme levels, we aggregated reports listing the following adverse events: MedDRA Preferred Terms: Autoimmune pancreatitis, pancreatitis acute, pancreatitis acute, pancreatitis bacterial, pancreatitis chronic, pancreatitis haemorrhagic, pancreatitis necrotizing, pancreatitis, pancreatic enzyme abnormality, pancreatic enzymes abnormal, and pancreatic enzymes increased.