scholarly journals PUK3 DRUG-INDUCED ACUTE RENAL FAILURE USING THE FDA ADVERSE EVENT REPORTING SYSTEM DATABASE

2011 ◽  
Vol 14 (3) ◽  
pp. A74
Author(s):  
A.M. Alhammad ◽  
M.A. Al Hawaj ◽  
A.J. Alsalman ◽  
Y.N. Alhashem ◽  
S.E. Harpe ◽  
...  
Keyword(s):  
Renal Failure ◽  
Adverse Event ◽  
Acute Renal Failure ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Induced ◽  
Event Reporting ◽  
System Database

scholarly journals Combining big data search analytics and the FDA Adverse Event Reporting System database to detect a potential safety signal of mirtazapine abuse

2020 ◽  
Vol 26 (3) ◽  
pp. 2265-2279 ◽  
Author(s):  
Dimitrios Spachos ◽  
Spyridon Siafis ◽  
Panagiotis Bamidis ◽  
Dimitrios Kouvelas ◽  
Georgios Papazisis
Keyword(s):  
Adverse Event ◽  
Odds Ratio ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Safety Signal ◽  
Event Reporting ◽  
System Database ◽  
Potential Safety ◽  
Different Sources

This study sought to detect a potential safety signal of mirtazapine abuse by combining two different sources of surveillance, specifically Google Analytics (Google, Inc., Mountain View, CA, USA) and the FDA Adverse Event Reporting System database. Data from the first quarter of 2004 to the second quarter of 2017 were collected and analysed. The search interest over time, the frequencies of abuse-related terms in the search analytics domain, and the odds ratio of abuse events in FDA Adverse Event Reporting System were determined. Correlations between the two aforementioned domains using quarterly data from the timeline series were also assessed. Our results suggest a positive correlation between abuse-related searches in the Google domain and abuse-related events in FDA Adverse Event Reporting System database. These results indicate that these methods can be used in combination with each other as a pharmacovigilance supplementary tool to detect drug safety signals.

scholarly journals Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045948
Author(s):  
Yeri Lee ◽  
Ahhyung Choi ◽  
Yunha Noh ◽  
Ha-Lim Jeon ◽  
Seung-Ah Choe ◽  
...  
Keyword(s):  
Adverse Event ◽  
Oral Contraceptives ◽  
Reporting System ◽  
Descriptive Analysis ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Third Generation ◽  
Event Reporting ◽  
System Database ◽  
Embolism And Thrombosis

ObjectivesTo detect the signals for drospirenone-containing oral contraceptives (DCOCs) and describe the reporting pattern of adverse events (AEs) caused by DCOCs compared with levonorgestrel/desogestrel/gestodene-containing (second/third generation) oral contraceptives.DesignA descriptive analysis of claims data.SettingThe Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database from 1 February 2008 to 31 December 2017.Outcome measuresSignals for DCOCs were identified using three data mining indices. The characteristics, death cases, and the annual pattern of AE reports were compared between DCOCs and second/third generation oral contraceptives.ResultsOf the 242 DCOC-related AEs, 54 signals were detected and 10 were identified as new signals that were not included in Korea, US and UK label. The newly detected signals include deep vein thrombophlebitis and frequent urination. Serious AEs were more likely to be reported with DCOCs (7.85%) than with second/third generation oral contraceptives (2.92%). Five deaths after use of DCOCs were reported with vascular AEs, such as pulmonary embolism and thrombosis, whereas one death after use of second/third generation oral contraceptives was reported with the cardiac arrest.ConclusionsWe identified 10 new signals related to DCOCs that were not included in the current label. Additionally, we found higher reports of the deaths and vascular AEs associated with DCOCs than with second/third generation oral contraceptives, which warrants careful monitoring to ensure the safe use of DCOCs.

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