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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Inflammation Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1452300

Safety Assessment of sulfasalazine: A Pharmacovigilance Study Based on FAERS Database

Provisionally accepted
Wangyu Ye Wangyu Ye *Yuan Ding Yuan Ding Meng Li Meng Li Zhihua Tian Zhihua Tian ShaoLi Wang ShaoLi Wang *Zhen Liu Zhen Liu *
  • Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

The final, formatted version of the article will be published soon.

    Background:Sulfasalazine is a widely used anti-inflammatory medication for treating autoimmune disorders such as ulcerative colitis(UC), Crohn's disease, and rheumatoid arthritis. However, its safety profile has not been systematically evaluated in real-world settings. By analyzing the FDA Adverse Event Reporting System (FAERS) database, we identified risk signals associated with adverse reactions to sulfasalazine, offering valuable insights for clinical decision-making and risk management.Methods:Reports of adverse events (AEs) associated with sulfasalazine, covering the period from Q1 2004 to Q4 2023, were extracted from the FAERS database. Detailed case information was aggregated to assess demographic characteristics. The associations between sulfasalazine and adverse events were evaluated using the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM).Results:We extracted 7,156 adverse event reports from the FAERS database where sulfasalazine was identified as the "Primary Suspect (PS)" drug. Using disproportionality analysis, we identified 101 preferred terms (PT) related to sulfasalazine across 24 organ systems. Notable adverse reactions consistent with the drug's labeling were observed, including Stevens-Johnson syndrome, agranulocytosis, eosinophilic pneumonia, and crystalluria. Additionally, novel positive signals not previously documented in the drug label were identified, including acute febrile neutrophilic dermatosis, aseptic meningitis, glomerulonephritis, and hepatosplenic T-cell lymphoma.Most of the adverse reaction findings in this study are consistent with previous clinical research, and we have also identified new potential AEs associated with sulfasalazine.These findings provide valuable insights for the safety monitoring and clinical application of sulfasalazine.

    Keywords: Sulfasalazine, FDA Adverse Events Reporting System, Adverse Drug Reaction, Adverse event, Pharmacovigilance

    Received: 20 Jun 2024; Accepted: 28 Aug 2024.

    Copyright: © 2024 Ye, Ding, Li, Tian, Wang and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Wangyu Ye, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
    ShaoLi Wang, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
    Zhen Liu, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.