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

作者全名："Li, Dongxuan; Wang, Hongli; Qin, Chunmeng; Du, Dan; Wang, Yalan; Du, Qian; Liu, Songqing"

作者地址："[Li, Dongxuan; Qin, Chunmeng; Du, Dan; Wang, Yalan; Du, Qian; Liu, Songqing] Chongqing Med Univ, Dept Pharm, Affiliated Hosp 3, Chongqing, Peoples R China; [Wang, Hongli] Chongqing Med Univ, Dept Pharm, Affiliated Yongchuan Hosp, Chongqing, Peoples R China; [Qin, Chunmeng; Wang, Yalan] Chongqing Med Univ, Coll Pharm, Chongqing, Peoples R China"

通信作者："Du, Q (通讯作者)，Chongqing Med Univ, Dept Pharm, Affiliated Hosp 3, Chongqing, Peoples R China."

来源：CLINICAL PHARMACOLOGY & THERAPEUTICS

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:001134957500001

JCR分区：Q1

影响因子：6.7

年份：2024

卷号：　

期号：　

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结束页：　

文献类型：Article; Early Access

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摘要："Timely identification and discontinuation of culprit-drug is the cornerstone of clinical management of drug-induced acute pancreatitis (AP), but the comprehensive landscape of AP culprit-drugs is still lacking. To provide the current overview of AP culprit-drugs to guide clinical practice, we reviewed the adverse event (AE) reports associated with AP in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database from 2004 to 2022, and summarized a potential AP culprit-drug list and its corresponding AE report quantity proportion. The disproportionality analysis was used to detect adverse drug reaction (ADR) signals for each drug in the drug list, and the ADR signal distribution was integrated to show the risk characteristic of drugs according to the ADR signal detection results. In the FAERS database, a total of 62,206 AE reports were AP-related, in which 1,175 drugs were reported as culprit-drug. On the whole, metformin was the drug with the greatest number of AE reports, followed by quetiapine, liraglutide, exenatide, and sitagliptin. Drugs used in diabetes was the drug class with the greatest number of AE reports, followed by immunosuppressants, psycholeptics, drugs for acid-related disorders, and analgesics. In disproportionality analysis, 595 drugs showed potential AP risk, whereas 580 drugs did not show any positive ADR signal. According to the positive-negative distribution of the ADR signal for drug classes, the drug class with the greatest number of positive drugs was antineoplastic agents. In this study, we provided the current comprehensive landscape of AP culprit-drugs from the pharmacovigilance perspective, which can provide reference information for clinical practice."

基金机构：Chongqing Medical University [KY22038]; Education Reform Project of Chongqing Municipal Education Commission [234035]

基金资助正文：This work was supported by the Research Incubation Project of the Third Affiliated Hospital of Chongqing Medical University (KY22038) and the Education Reform Project of Chongqing Municipal Education Commission (234035).