Vancomycin and linezolid: severe cutaneous adverse reactions to drugs

Background: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Acute Generalized Exanthematous Pustulosis (AGEP), pose significant therapeutic challenges. Vancomycin and linezolid have been linked to these life-threatening conditions, necessitating a better understanding of their associated risks.

Methods: We conducted a retrospective analysis using data from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality and Bayesian statistical analyses were applied to evaluate the associations between vancomycin, linezolid, and SCARs, comparing the outcomes induced by these drugs.

Results: Of the 11,737,133 data, there were a total of 1024 vancomycin-associated SCARs and 125 cases of linezolid-associated SCARs. Vancomycin was strongly associated with DRESS, showing a Reporting Odds Ratio (ROR) of 53.79 (95% CI: 49.75-58.16), Proportional Reporting Ratio (PRR) of 50.38, and Empirical Bayesian Geometric Mean (EBGM) of 2.32. For SJS and TEN, vancomycin reported RORs of 8.04 and 15.63, respectively. Linezolid demonstrated lower associations, with RORs of 5.14 for DRESS and 2.36 for SJS.

Conclusions: Vancomycin presents a higher risk of SCARs compared to linezolid, particularly for DRESS. Underscoring the need for cautious use and the potential benefit of personalized medicine practices to improve patient safety.