(190) Pancreatic Carcinoma Associated with Liraglutide Use: Adverse Events- Signal Review

Publication Number: 521

Background: Liraglutide is a GLP-1 analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor. Pancreatic cancer occurs when cells in the pancreas grow, divide, and spread uncontrollably, forming a malignant tumor . Saudi Food and Drug authority (SFDA) has detected a signal from medical literature of pancreatic cancer in association with Liraglutide use and conducted this signal review based on that.

Objectives: The purpose of this signal review is to evaluate the risk of Pancreatic carcinoma in association with Liraglutide use.

Methods: On November 16th 2021, Signal Detection team at SFDA has conducted a retrospective search in the World Health Organization (WHO) database (Vigibase) and The National Pharmacovigilance Center (NPC) in Saudi Arabia database. The author used (Liraglutide) as WHODrug substance term and (Pancreatic carcinoma) as reaction preferred term (PT) (MedDRA) to retrieve all reported cases between 2009 and 2021. Furthermore, literature screening was done for eligible publications using google scholar.

Results: Local Cases: The search in (NPC) database resulted in zero cases. Global Cases: the search in (WHO) database resulted in 807 Individualized Case Safety Reports (ICSRs). A causality assessments was applied on cases with completeness score (>.0.9) (N=45). It resulted in 19 cases with possible association, 5 cases with unlikely association. Twenty-one cases were unassessable .
Twenty ICSRs reported fatal outcome. Data mining: The disproportionality between a drug and event was measured using Information Component (IC) value that developed by WHO Uppsala Monitoring Centre. A Positive cumulative value (IC = 5) for spontaneous reporting suggests that the reported cases of Liraglutide and pancreatic carcinoma have been observed more than expected when compared to other medications in the WHO database. Literature: A case report published in 2021 describes a 71-year-old man who was diagnosed with type two diabetes 25 years ago. He presented at the hospital with discomfort in the abdomen. A diagnoses of pancreatic ductal adenocarcinoma was made. His medical records showed that liraglutide was added to his treatment regimen 20 months ago. The causality was estimated by the Naranjo Adverse Drug Reaction Probability scale and WHO-Uppsala Monitoring Centre (WHO-UMC) system and resulted in possible association.

Conclusions: The weighted cumulative evidences identified from causality assessment of the reported cases, and literature are sufficient to support a causal association between liraglutide and the risk of pancreatic carcinoma. This review emphasizes the need for a large data set to study the association. Health regulators and health care professionals must be aware of this potential risk.