Fatal outcome related to drug reaction with eosinophilia and systemic symptoms: a disproportionality analysis of FAERS database and a systematic review of cases

Front Immunol. 2024 Dec 16:15:1490334. doi: 10.3389/fimmu.2024.1490334. eCollection 2024.

Abstract

Background: Drug rash with eosinophilia and systemic symptoms (DRESS) is a life-threatening severe cutaneous adverse reaction.

Objective: This study aims to study fatal DRESS cases using FAERS database and systematic review.

Methods: Data of the FDA Adverse Event Reporting System (FAERS) database were extracted and manipulated. Articles from Pubmed, Embase and CINAHL databases were screened.

Results: 0.13% of the adverse events submitted to FAERS was identified as DRESS and the percentage of fatal cases was up to 6.62%. The top five drugs calculated to induce DRESS with the highest number of reported cases were allopurinol, lamotrigine, vancomycin, amoxicillin and carbamazepine. The top five drugs statistically related to fatal outcome with the highest number of reported cases were allopurinol, vancomycin, trimethoprim, sulfamethoxazole and lamotrigine. Skin manifestations remained the main reason for admission and the average time from dose to rash onset was 27.19 days. The most commonly cited culprit medication type were antibiotics (50.00%), anti-gout agents (15.38%) and anti-epileptic drug (11.54%).

Conclusions: We discussed fatal cases of DRESS through FAERS system and case reports, hoping to raise awareness when using relevant drugs.

Keywords: FDA adverse event reporting system; disproportionality analysis; drug adverse reaction; drug reaction with eosinophilia and systemic symptoms; drug-induced hypersensitivity syndrome; fatal cases; systematic review.

Publication types

  • Systematic Review

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems* / statistics & numerical data
  • Aged
  • Databases, Factual
  • Drug Hypersensitivity Syndrome* / epidemiology
  • Drug Hypersensitivity Syndrome* / etiology
  • Drug Hypersensitivity Syndrome* / mortality
  • Fatal Outcome
  • Female
  • Humans
  • Male
  • Middle Aged
  • United States / epidemiology
  • United States Food and Drug Administration

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. National Natural Science Foundation of China (82304456) from C-SL, National Natural Science Foundation of China (82304638) from XL and National High Level Hospital Clinical Research Funding (2022-PUMCH-B-059)from BZ.