RESUMO
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.