Korean J Clin Pharm.  2023 Jun;33(2):122-127. 10.24304/kjcp.2023.33.2.122.

Signal Detection of Adverse Event of Metoclopramide in Korea Adverse Event Reporting System (KAERS)

• Jang MG
• Lee Y
• Jeong H
• Shin KH

• KMID: 2544334
• DOI: http://doi.org/10.24304/kjcp.2023.33.2.122

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.

Keyword

Adverse event; korea adverse event reporting system (KAERS); metoclopramide; proportionality analysis; signal detection