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KMID : 1011320120050020078
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Journal of Pharmacoepidemiology and Risk Management
2012 Volume.5 No. 2 p.78 ~ p.86
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Signal Detection and Evaluation for Gabapentin Using WHO Triage Logic in Korean Spontaneous Adverse Events Reporting Data
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Kim Ji-Young
Seong Jong-Mi
Choi Nam-Kyong
Lee Joong-Yub
Park Byung-Joo
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Abstract
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Objective: To detect adverse drug reaction (ADR) signals of gabapentin using Korean spontaneous adverse events (AEs) reporting database.
Methods: We used the database on spontaneously reported AEs from Regional Pharmacovigilance Centers from June 2009 to December 2010. All AEs were reported by the healthcare professionals. Data mining was used to analyze the reports of gabapentin compared to all other drugs. We calculated proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) of the Bayesian Confidence Propagation Neural Network (BCPNN). The AE detected by more than one index among PRR, ROR and IC was defined as a signal. We identified whether the detected signals were listed on the labels or not. We evaluated all AEs and serious adverse events (SAEs) by using Triage logic which introduced by WHO Uppsala Monitoring Centre (UMC).
Results: Reports of gabapentin were 187. Among the total 155,053 drug-AE pairs, 583 drug-AE pairs were for gabapentin. Total 58 AEs were detected as signals of gabapentin. Detected AEs compared to all other drugs, three of them were unexpected signals which not listed on the latest label. There were 14 SAEs, nine of them were required hospitalization or prolongation of existing hospitalization and others were other medically serious adverse events. Two of the SAEs were potentially associated with a DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) syndrome: rash, fever, and liver function abnormality.
Conclusion: SAE associated with DRESS syndrome could be considered as an unexpected AE based on the current label of gabapentin in Korea, which needs further investigation on their causal association.
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KEYWORD
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Data mining, Signal, Spontaneous adverse events reporting, Gabapentin, DRESS syndrome
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