(349) Safety Analysis of Adverse Drug Reactions in United States: A 21-Year descriptive Study of FDA Adverse Event Reporting System

Background: Adverse drug reactions (ADRs) pose a significant threat to patient safety and can have a substantial impact on healthcare costs

Objectives: To conduct a descriptive analysis of ADRs reported in the United States, focusing on serious reactions, trend analysis, sex and age differences, and identifying the top medications and reactions associated with ADRs.

Methods: A retrospective analysis of ADRs reports from the OpenFDA database was conducted to examine ADRs in the United States from 2004 to 2023. The OpenFDA database serves as a publicly accessible repository for reporting ADRs. Data for this study were sourced from the database and imported from JSON files into PostgreSQL databases for subsequent analysis. All reported ADRs were systematically analyzed, with a particular emphasis on identifying serious reactions and specific medications. We reported the annual numbers of total and serious ADRs over time (trend analysis), the proportion of total and serious reports by reported sex (female vs. male) and age groups ( < 18, 18-44, 45-64, and ≥ 65 years), and the identification of top medications and reactions associated with ADRs. All analyses were restricted to drugs listed as primary suspects in total and serious Adverse Drug Events (ADEs), such as death, disability, and hospitalization, and top medications and reactions were identified and ranke

Results: We observed a significant increase in total and serious ADRs from 2004 (390 reports) to 2014 (110 4200 reports) (p-values < 0.05). The proportion of total and serious ADRs reported was higher in females (51% vs. 39% for serious ADRs) and individuals aged 45 and above (72% vs 28% for serious ADRs). Lenalidomide (3.6%) was the most reported medication causing ADRs. Disease-modifying antirheumatic drugs (DMARDs) such as adalimumab (3.6%) and etanercept (3.1%) were the most frequent classes of medication causing ADRs overall and for both males and females. Lenalidomide and rivaroxaban were the most frequent medications reported to cause death or hospitalization, accounting for 9.2% and 5.6% of the serious reports, respectively. The most frequent adverse reactions were death, fatigue, and dyspnea, with death being the most frequent serious ADRs, accounting for 11.0% of serious reports. Pneumonia was the most frequent reaction leading to hospitalization, representing 0.87% of the total reports.

Conclusions: The study provides valuable insights into ADR reporting patterns and trends in the United States. These findings offer opportunities for generating new research hypotheses using more advanced analytical methods and comprehensive databases