Drug-Induced Acute Pancreatitis: A Real-World Pharmacovigilance Study Using the FDA Adverse Event Reporting System...

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Drug Safety

Background:

• Drug-induced acute pancreatitis (AP) necessitates prompt culprit-drug identification and withdrawal for effective management.
• A comprehensive understanding of drugs associated with AP is currently lacking, hindering clinical practice.
• This study aims to provide an updated overview of AP culprit-drugs using real-world data.

Approach:

• Analyzed 62,206 AP-related adverse event reports from the FDA Adverse Event Reporting System (FAERS) database (2004-2022).
• Identified 1,175 potential culprit drugs and assessed their association with AP using disproportionality analysis to detect adverse drug reaction (ADR) signals.
• Integrated ADR signal distribution to characterize drug risks.

Key Points:

• Metformin, quetiapine, liraglutide, exenatide, and sitagliptin were among the drugs with the highest number of AP-related adverse event reports.
• Diabetes medications constituted the most frequently reported drug class, followed by immunosuppressants and psycholeptics.
• Disproportionality analysis revealed 595 drugs with potential AP risk, with antineoplastic agents showing the highest proportion of positive ADR signals.

Conclusions:

• This pharmacovigilance study presents a comprehensive landscape of AP culprit-drugs based on extensive FAERS data.
• The findings offer valuable reference information for clinicians to improve the diagnosis and management of drug-induced AP.
• Highlights the importance of ongoing drug safety surveillance for identifying and mitigating risks associated with AP.