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비만치료제 의약품이상사례 실마리정보 검색- 국내 의약품 이상사례보고시스템 자료를 활용하여 -

Signal detection of obesity treatments adverse drug reaction using Korea Adverse Event Reporting System Database

약학회지 2020년 64권 6호 p.485 ~ 495
신호준, 신호선, 박혜경,
소속 상세정보
신호준 ( Shin Ho-June ) - Sungkyunkwan University School of Pharmacy
신호선 ( Shin Ho-Sun ) - Sungkyunkwan University School of Information and Communication Engineering
박혜경 ( Park Hye-Kyung ) - Sungkyunkwan University School of Pharmacy

Abstract


The objective of this study was detection of signals corresponding to adverse drug reactions following obesitytreatments using the Korea Adverse Event Reporting System Database. Eight obesity drugs recommended in the obesitytreatment guidelines were analyzed for adverse events reported from January 2009 to December 2018. The ratio ofreporting, ratio of reporting odds, and information components were analyzed, and the case in which all three criteria weremet was detected as a signal. Signals that were not included in the label were classified as new signals. In the case ofphentermine, phendimetrazine, diethylpropion, lorcaserin, mazindol, liraglutide, or listat, and naltrexone/bupropion, therewere 2, 10, 5, 6, 1, 10, 7, and 5 confirmed cases of signal detection, respectively. No new signal was detected forphentermine and mazindol adverse events. For phendimetrazine, diethylpropion, lorcaserin, liraglutide, orlistat, andnaltrexone/bupropion, there were 5, 2, 1, 7, 4, and 1 cases of new signals, respectively. This study assessed signal detectionrelated to adverse events for eight obesity drugs. It is necessary to consider whether permission information should bereflected through continuous research on the detection of signals that are not reflected in the existing permits.

키워드

data mining; signal detection; adverse events; spontaneous reporting; obesity treatments

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