Detection and Evaluation of Adverse Drug Reaction Signals of Antidepressants Based on FDA Adverse Event Reporting System Database

摘要

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.