Signal detection and analysis of sulfasalazine adverse reaction events based on the US FDA adverse event reporting database.

BACKGROUND

Based on real data from the FDA Adverse Event Reporting System (FAERS), we explored and evaluated the adverse reactions (ADRs) of sulfasalazine (SSZ) in the first quarter of 2004-2023 to provide a reference basis and early warning for the safe use of SSZ in the clinic.

RESEARCH DESIGN AND

METHODS

The reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM) were used as measures of SSZ-associated adverse events (AEs) signals, mining for potential positive signals between SSZ and AE.

RESULTS

In this study, a total of 5327 case reports related to SSZ in the last 20 years involving 25 system organ classes (SOCs) were collected in FAERS. The AEs of SSZ were mainly focused on Immune system disorders (n = 1621, IC025 = 2.86), Blood and lymphatic system disorders (n = 638, IC025 = 2.4), and others. In addition, we found 41 adverse reactions not mentioned in the specification, including oculomucocutaneous syndrome (n = 12, IC025 = 4.86), wegener's granulomatosis(n = 6, IC025 = 4.05) and reproductive system aspects.

CONCLUSION

Significant new AEs signals were observed in this study and may provide important support for clinical monitoring and risk identification in SSZ.