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Signal detection of obesity treatments adverse drug reaction using Korea Adverse Event Reporting System Database
Yakhak Hoeji 2020;64(6):485-495
Published online December 31, 2020
© 2020 The Pharmaceutical Society of Korea.

Ho June Shin*, Ho Sun Shin**, and Hye Kyung Park*,#

*School of Pharmacy, Sungkyunkwan University
**School of Information and Communication Engineering, Sungkyunkwan University
Correspondence to: Hyekyung Park, School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do, 16419, Korea
Tel: +82-31-290-7763
E-mail: phk94@skku.edu
Received June 27, 2020; Revised October 12, 2020; Accepted December 16, 2020.
Abstract
The objective of this study was detection of signals corresponding to adverse drug reactions following obesity treatments using the Korea Adverse Event Reporting System Database. Eight obesity drugs recommended in the obesity treatment guidelines were analyzed for adverse events reported from January 2009 to December 2018. The ratio of reporting, ratio of reporting odds, and information components were analyzed, and the case in which all three criteria were met was detected as a signal. Signals that were not included in the label were classified as new signals. In the case of phentermine, phendimetrazine, diethylpropion, lorcaserin, mazindol, liraglutide, or listat, and naltrexone/bupropion, there were 2, 10, 5, 6, 1, 10, 7, and 5 confirmed cases of signal detection, respectively. No new signal was detected for phentermine and mazindol adverse events. For phendimetrazine, diethylpropion, lorcaserin, liraglutide, orlistat, and naltrexone/bupropion, there were 5, 2, 1, 7, 4, and 1 cases of new signals, respectively. This study assessed signal detection related to adverse events for eight obesity drugs. It is necessary to consider whether permission information should be reflected through continuous research on the detection of signals that are not reflected in the existing permits.
Keywords : data mining; signal detection; adverse events; spontaneous reporting; obesity treatments


December 2020, 64 (6)
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