Incretin-mimetics associated pancreatitis: evidence from the spontaneous adverse drug reactions reporting in Italy.
OBJECTIVE
New incretin-mimetics increased the treatment options for type 2 diabetes mellitus. Studies on the safety of incretin-based therapy showed a risk of hypersensitivity reactions, acute pancreatitis, renal failure, infection, thyroid and pancreas cancer. We contributed to safety assessment of these new drugs by evaluating the spontaneous adverse drug reactions (ADRs) reporting in Italy.


METHODS
Reports of suspected ADRs associated with incretin-mimetics were selected from the Italian Spontaneous ADR Reporting Database. For a subgroup of cases belonging to the Hospital of Cento (Ferrara), levels of pancreatic enzymes, amylase and lipase, before and after the therapy with the incretin-mimetics were available.


RESULTS
As of December 2012, the reports of ADR associated with hypoglycemic drugs (excluding insulin) were 2443, 1169 (47.85%) concerned the incretin-mimetics. A total of 90 reports described pancreatitis (44) and elevated pancreatic enzymes (46). Out of 90 cases, 34 were serious (37%). Data on amylase/lipase values for 10 patients were provided and an analysis of the published literature was performed.


CONCLUSIONS
Our data from the daily clinical practice add up and confirm the information available on the association between incretin-mimetics and pancreatic damage and suggest caution in the prescribing of these new drugs and a close monitoring of exposed patients.
Hospital and Community Pharmaceutical Assistance, Department of Pharmacy, Local Health Authority of Ferrara , Ferrara , Italy.
Marcello
M
Delfino
Domenico
D
Motola
Angela
A
Benini
Gian Pietro
GP
Franzè
Marcella
M
Barotto
Anna
A
Campi
Vincenzo Maria
VM
Monda
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology*; D005260:Female; D006801:Humans; D054795:Incretins / Q000009:adverse effects*; D007558:Italy; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000139:chemically induced* / Q000209:etiology*; D055815:Young Adult
D054795:Incretins