Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Signal Detection of Adverse Event of Metoclopramide in Korea Adverse Event Reporting System (KAERS)

의약품부작용보고시스템을 이용한 메토클로프라미드의 이상사례 실마리정보 도출

  • Min-Gyo Jang (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University) ;
  • Yeonghwa Lee (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University) ;
  • Hyunsuk Jeong (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University) ;
  • Kwang-Hee Shin (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University)
  • 장민교 (경북대학교 약학대학, 약학연구소) ;
  • 이영화 (경북대학교 약학대학, 약학연구소) ;
  • 정현숙 (경북대학교 약학대학, 약학연구소) ;
  • 신광희 (경북대학교 약학대학, 약학연구소)
  • Received : 2023.05.01
  • Accepted : 2023.06.14
  • Published : 2023.06.30
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Abstract

Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

Keywords

Acknowledgement

본 연구는 한국연구재단 이공학개인기초기본연구의 지원사업 (NRF-2018R1D1A1B07050267) 및 한국연구재단의 4단계 두뇌한국21 사업(4단계 BK21 사업)으로 지원된 연구이다(5199990614732).

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