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KMID : 1146320180060010043
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Journal of Health Technology Assessment
2018 Volume.6 No. 1 p.43 ~ p.49
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Signal Detection of Adverse Drug Reaction of Zolpidem Using the Korea Adverse Event Reporting System Database
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Han Joon-Woo
Kim Seon-Ji
Ko Young-Jin
Park Byung-Joo
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Abstract
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Objectives: To detect signals of adverse drug reactions of zolpidem by data mining using the Korea Adverse Events Reporting System (KAERS) database.
Methods: This study used the Korea Institute of Drug Safety KAERS Database (KIDS-KD) reported from December 1988 to December 2015 through KAERS. Among them, signals were detected by data mining on the adverse events of zolpidem. In this study, we defined a signal that satisfies all three indices: proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC). And we checked whether the detected signals exist in drug labels in Korea, the United States, the United Kingdom, Germany, France, and Japan.
Results: A total of 3012517 adverse event-drug pairs were reported from 1988 to 2015, of which 11814 were associated with zolpidem. Fifty nine signals were satisfying the criteria (PRR, ROR, and IC). Based on this, the detected signals were compared with the drug labels of six countries. As a result, 17 signals were not included in all the drug labels of 6 countries. Schizophrenic reaction, paronychia, dry eyes, intervertebral disc disorder, duodenal ulcer, extravasation, lactation nonpuerperal, lymphoedema, carcinoma squamous, hypercalcaemia, brain neoplasm benign, colon carcinoma, colitis ulcerative, renal papillary necrosis, ovarian cyst, hyperphosphataemia, and fluid overload.
Conclusion: We identified 17 new signals of zolpidem that do not exist in drug labels in six countries. However, further pharmacoepidemiological studies should be needed to evaluate the causality of the signals with zolpidem.
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KEYWORD
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Zolpidem, Korea Adverse Events Reporting System Database, Data mining, Pharmacovigilance, Korea Institute of Drug Safety and Risk Management, Pharmacoepidemiology
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