Adverse Event Reporting Patterns of Newly Approved Drugs in the USA in 2006: An Analysis of FDA Adverse Event Reporting System Data

Drug Safety ◽  
2013 ◽  
Vol 36 (11) ◽  
pp. 1117-1123 ◽  
Author(s):  
Pankdeep Chhabra ◽  
Xing Chen ◽  
Sheila R. Weiss
Keyword(s):  
Adverse Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
The Usa ◽  
System Data ◽  
Approved Drugs

Using Data Mining to Predict Safety Actions from FDA Adverse Event Reporting System Data

2007 ◽  
Vol 41 (5) ◽  
pp. 633-643 ◽  
Author(s):  
Alan M. Hochberg ◽  
Stephanie J. Reisinger ◽  
Ronald K. Pearson ◽  
Donald J. O’Hara ◽  
Kevin Hall
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
System Data ◽  
Using Data

Exploring pharmacogenetic difference using adverse event database: an example of clopidogrel and cardiovascular events

2020 ◽  
Vol 21 (16) ◽  
pp. 1157-1168
Author(s):  
Kyung-In Joung ◽  
Kwang Hyun Kim ◽  
Cheng-Yang Hsieh ◽  
Ju-Young Shin
Keyword(s):  
Adverse Event ◽  
Odds Ratio ◽  
Cardiovascular Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Event Reporting ◽  
System Database ◽  
System Data

Background: Poor clopidogrel metabolizers, carrying a cytochrome P450 2C19 loss-of-function allele, are more frequent among East Asians than Caucasians/White. Materials & methods: The Korea adverse event reporting system database and a case/noncase study design were used to examine the disproportionality of cardiovascular events following clopidogrel use. The US FDA’s adverse event reporting system database was also analyzed for comparison. Results: In the Korea adverse event reporting system data, the clopidogrel reporting odds ratio for cardiovascular events was 7.34, more than double that of ticagrelor. In the FDA’s adverse event reporting system data, the clopidogrel reporting odds ratio was 4.69, lower than that of ticagrelor. Adjustment for covariates did not change the trend. Conclusion: Considering the prevalence of poor clopidogrel metabolizers and the reported cardiovascular events among Koreans, rigorous clinical management is required for clopidogrel users.

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