Background: Drug-induced pancreatitis (DIP) has been increasingly recognized owing to the increased use of pharmacotherapy; however, valproate sodium (VPA)-associated DIP remains uncommon, particularly in adolescents, though severe and life-threatening cases have been documented in this population. We report an adolescent patient with epilepsy who developed DIP following long-term VPA therapy and further investigate the risk of antiepileptic drug (AED)-related pancreatitis through an analysis of the FDA Adverse Event Reporting System (FAERS) database.
Methods: We present a case of an adolescent male with epilepsy who developed DIP after VPA treatment. OpenVigil 2.1 was used to conduct a pharmacovigilance analysis of all AED-related adverse events (AEs) reported to the FAERS up to June 2024. Signal detection was performed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR).
Results: Among 136,681 cases from 104 countries, 2237 (1.64%) were associated with acute pancreatitis (AP), including 918 serious cases. All evaluated AEDs - except brivaracetam - had ROR and PRR values >1, indicating a potential risk of pancreatitis. The highest-risk AEDs were amobarbital, quetiapine, VPA, and carbamazepine.
Conclusion: This study reinforces the association between VPA and AP while providing a broader pharmacovigilance assessment of AED-induced pancreatitis. Clinicians should remain vigilant when prescribing AEDs, particularly to high-risk patients, given the potential of serious pancreatic toxicity.
Keywords: Drug-induced pancreatitis; FAERS; adverse effect; antiepileptic drug; valproate sodium.
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