Valproate sodium-associated acute pancreatitis: a case report and systematic analysis of antiepileptic drug adverse events in FAERS.

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.