TITLE:
Detection and Evaluation of Adverse Drug Reaction Signals of Antidepressants Based on FDA Adverse Event Reporting System Database
AUTHORS:
Chao Ran, Hu Zhou, Chao Tan, Juntao Tan, Zhengyu Zhang, Wenlong Zhao
KEYWORDS:
Antidepressants, SSRIs, Adverse Drug Reactions, Data Mining, Signal Detection
JOURNAL NAME:
Open Journal of Depression,
Vol.9 No.2,
May
27,
2020
ABSTRACT: Background: Pre-marketing clinical research of drugs can not completely solve the
safety problems in the process of wide application of drugs post-marketing, so
it is necessary to re-evaluate the safety and effectiveness of drugs after
marketing. Objective: To detect and analyze the adverse drug reaction (ADR)
signals of Selective Serotonin Reuptake Inhibitor (SSRIs) post-marketing and
provide references for clinical rational drug use. Methods: Reporting
Ratio (ROR) method was used to mine the adverse reaction signals of SSRIs in
the Adverse Reaction Reporting System (ARES) of the Food and Drug
Administration of the United States (FDA), and the results were analyzed and
evaluated. Results: Adverse Drug Events (ADEs) of fluoxetine,
fluvoxamine, paroxetine, sertraline and citalopram were 40,217,
2907, 52,439, 63,849 and 42,588 cases respectively. After ROR test, there were 187 ADR signals of the
five drugs, among which ADR was most prominent in psychiatric and nervous
system. It mainly includes adverse reactions such as anxiety, depression,
suicidal ideation, 5-HT syndrome, withdrawal syndrome and so on. Conclusion: The study based on ADR signals in the real world is helpful to evaluate the
post-marking safety drugs and provide references for safety in clinical
medication.