Severe cutaneous adverse reactions due to antibiotics therapy: a pharmacovigilance analysis of FDA adverse event reporting system events

Abstract

BACKGROUND: The aim of this study was to monitor, identify and evaluate severe cutaneous adverse reactions (SCAR) induced by antibiotics in patients. METHODS: Disproportionality algorithms were performed in data mining to screen suspected SCAR after using nine categories of antibiotics based on the FDA's Adverse Event Reporting System (FAERS) from January 2004 to December 2022. The drug information and demographic characteristics of antibiotic-associated SCAR were also investigated. RESULTS: The FAERS database received 12,212 antibiotic-associated SCAR cases. Approximately half of the SCAR patients were females, the majority of them were adults aged 18-65 years (48.35%), and 47.68% of SCAR patients required hospitalization. The highest SCAR signals RORs (95% CI) for antibiotics were: sulfonamides 23.30 (22.05-24.62), glycopeptides 21.27 (20.26-22.33), penicillins 16.00 (15.44-16.59), carbapenems 10.46 (9.57-11.44), and cephalosporins 13.27 (12.57-14.00). Cefotaxime, sulfamethoxazole/trimethoprim, cefixime, vancomycin, piperacillin, ceftriaxone, amoxicillin, and meropenem had stronger associations with the SCAR than the other antibiotics. However, sulfonamides-associated SCAR cases had the lowest fatality rate (6.23%), penicillin-associated SCAR cases had the highest hospitalization rate (54.16%), and carbapenem-associated SCAR cases seemingly resulted in the highest risk of death (19.03%). CONCLUSION: Data mining of FAERS identified 30 antibiotic-associated SCAR signals, and provided a referable evidence of the occurrence, characteristics and prognosis of antibiotic-related SCARs.