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- Title
Combining big data search analytics and the FDA Adverse Event Reporting System database to detect a potential safety signal of mirtazapine abuse.
- Authors
Spachos, Dimitrios; Siafis, Spyridon; Bamidis, Panagiotis; Kouvelas, Dimitrios; Papazisis, Georgios
- Abstract
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.
- Subjects
PREVENTION of drug side effects; CHI-squared test; CLONAZEPAM; INFORMATION retrieval; PATIENT safety; STATISTICS; SUBSTANCE abuse; UNITED States. Food &; Drug Administration; SEARCH engines; DATA analysis; CITALOPRAM; MIRTAZAPINE; DESCRIPTIVE statistics; DATA analytics; MANN Whitney U Test; KRUSKAL-Wallis Test
- Publication
Health Informatics Journal, 2020, Vol 26, Issue 3, p2265
- ISSN
1460-4582
- Publication type
Article
- DOI
10.1177/1460458219901232