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Valproate-Induced Malformation In Epilepsy: Data Mining of Canadian Adverse Reaction Monitoring Program Safety Reports
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| Author:
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HARDIK BHATT, TUSHAR DESAI
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| Abstract:
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Purpose: In present investigation, we analysed process and preliminary results of combining data from Canadian Adverse Reaction Monitoring Program databases for monitoring of anti-epileptic drug safety.
Objective: The objective of present investigation was to extract data related to adverse events associated with Valproate from Canadian Adverse Reaction database for possible congenital anomaly signal detection of Valproate with qualitative analysis and also to evaluate the frequency of the Valproate induced malformation within different stratified groups.
Methods: A total of 4855 case reports of anti-epileptic drugs within period of January 2000 to June 2016 were downloaded from database. There were 1066 cases for Valproate and its analogue reported during this interval. These reports containing information of adverse events associated with Valproate were investigated. Statistical pharmacovigilance tools were used for quantitative signal detection of drug-related adverse reactions, which includes proportional reporting ratio, 95% confidence interval of proportional reporting ratio, the reporting odds ratio and Reporting ratio.
Results: Total of 6 reports related to Valproate-induced malformation was obtained from Canadian Adverse Reaction database. For Valproate-induced malformation, the proportional reporting ratio, reporting odds ratio and reporting ratio was found to be 2.92, 2.95 & 2.15 respectively. Lower and upper limits of 95% confidence interval of proportional reporting ratio were found to be 1.047 & 8.175 respectively.
Conclusion: Data mining from Canadian Adverse Reaction database was found useful for examining Valproate-induced malformation related adverse event. The data strongly suggest the necessity of risk minimization measures for the congenital anomaly associated risk with anti-epileptic drugs.
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| Keyword:
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Valproate, Signal detection, Adverse drug events, Malformation
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| EOI:
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| DOI:
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