Korean J Clin Pharm.  2022 Mar;32(1):1-7. 10.24304/kjcp.2022.32.1.1.

Signal detection for adverse event of varenicline in Korea Adverse Event Reporting System

• Jang MG
• Gu HJ
• Kim J
• Shin KH

• KMID: 2527744
• DOI: http://doi.org/10.24304/kjcp.2022.32.1.1

Abstract

Objective
The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea.
Methods
This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA).
Results
A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

Keyword

Adverse event; data mining; signal detection; smoking cessation; varenicline