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KMID : 1011320090020010038
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Journal of Pharmacoepidemiology and Risk Management
2009 Volume.2 No. 1 p.38 ~ p.44
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Signal Detection of Sildenafil in Karean Spontaneous Adverse Event Reports
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Seong Jong-Mi
Choi Nam-Kyong
Park Byung-Joo
Jung Sun-Young
Kim Ye-Jee
Lee Joong-Yub
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Abstract
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Objective: To detect signals associated with sildenafil using Korean spontaneous adverse events (AEs) reporting database.
Methods: We used the data based on spontaneously reported AEs between December 1988 and June
2006 to Korean Food and Drug Administration. Data mining was used to analyze the reports of sildenafil, the
most frequently reported drug during the study period, against a background of all reports suspected by other
drugs in the database. We generated drug-AE pairs of reports completely informative in drug and AE and calculated proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The AE
which was detected by more than one index among PRR, ROR and IC was defined as signal. And we identified
whether the detected signals were listed on the labels or not.
Results: The Korean spontaneous AEs reporting database contains 4,592 reports from December 1988 and June 2006. The reports which were attributed to sildenafil were 800 reports. Among the total 8,737 drug-AE pairs, 1,241 drug-AE pairs were for sildenafil and there were 165 kinds of AEs. Twenty seven AEs were detected as sildenafil’s signal. Among them, 5 AEs including glaucoma, flatulence, muscae volitantes, viral hepatitis and penile hemorrhage were not listed on the labels.
Conclusion: We detected signals of sildenafil which were not listed on the labels. Careful monitoring and further investigation to evaluate the causal association for detected signals will be needed. And this study shows the potential of Korean spontaneous AEs reporting database in analyzing data on drug safety.
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KEYWORD
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Data mining, Signal, Spontaneous adverse event reporting, Sildenafil
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