의약품유해사례보고를 통한 아리피프라졸의 실마리정보 검색 및 안전성정보 개발

Signal Detection and Safety Information Generation of Aripiprazole in Spontaneous Adverse Event Reports Database

본 연구는 비정형 항정신병제인 아리피프라졸에 대하여 국내 유해사례보고 자료를 토대로 실마리정보를 검색하고 평가하여 안전성정보를 생산하고자 실시하였다. 한국의약품안전관리원에서 구축한 의약품유해사례보고 데이터베이스로부터 1989년부터 2012년까지 2,565건의 아리피프라졸-유해사례 조합을 추출하였고, PRR, ROR, IC값을 활용한 데이터마이닝기법 및 우선순위화 알고리즘을 사용하여 78개의 실마리정보를 검색하였다. 이 중 국내 허가사항에 반영되어 있지 않은 20개의 유해사례에 대해 국외 허가사항 및 문헌을 검토하는 등 실마리정보 평가과정을 거쳐 안전성정보를 생산하였다. 아리피프라졸에 대한 최종 안전성정보로는 등통증, 코피, 건성안, 사정장애가 있었고, 이는 2013년 4월 식품의약품안전처의 조치로 국내 허가사항의 주의사항에 반영되었다.

Objective Korea Institute of Drug Safety and Risk Management works for signal detection and safety information generation by analyzing spontaneous adverse event reports database. As the number of reports and detected signals of aripiprazole by each data mining indices were more than other drugs, aripiprazole was selected as a subject of study. Methods 1989–2012 spontaneous reporting database was analyzed and the model drug ingredient was aripiprazole. We estimated proportional reporting ratio, reporting odds ratio, and information component for data mining. Then we assessed the causality through review of local and foreign drug labels and literatures. Results In reconstructed 1989–2012 spontaneous reporting database, there were 2,062 reports on aripiprazole and 2,565 aripiprazole-adverse events pairs. As a result of data mining analysis and signal prioritization, 78 adverse events were detected, 20 adverse events of them were not included in drug label. After literature review, back pain, epistaxis, xerophthalmia and ejaculation disorder were generated as novel safety information on aripiprazole. Conclusion Those 4 novel safety informations of Aripiprazole, back pain, epistaxis, xerophthalmia and ejaculation disorder had become listed on the local label in April 2013.