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Pancreatitis induced by Peg-aspargase in children: a real-world pharmacovigilance analysis based on FDA Adverse Event
Wenwen Zhang1, Bin Luo2, Zhuo Liu1
1Department of Pharmacy, Xi'an Children's Hospital, The Affiliated Children Hospital of Xi'an Jiaotong University, Xi'an, China.
Abstract:
This study analyzed FAERS data to evaluate pegaspargase safety in pediatric acute lymphoblastic leukemia treatment. Among 21,161,817 reports, 847 identified pegaspargase as the primary suspect drug, revealing adverse events (AEs) across 26 organ systems. Disproportionality analysis identified four previously unlisted AEs. Critically, pegaspargase-associated pancreatitis incidence showed significant age-dependence (χ²=8.219, p < 0.05). These findings address the knowledge gap in real-world, long-term pediatric safety profiles and provide crucial clinical references for safer medication use in children.
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