Pharmacoepidemiology and drug safety · 2025
Antibiotics and Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome: Analysis of Brazilian Pharmacovigilance Registries.
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de Camargo Marcelo Bueno, Ribeiro-Vaz Inês, de Cássia Bergamaschi Cristiane, Silva Marcus Tolentino
Аннотация
BACKGROUND AND PURPOSE: This study investigated the association between the use of antibiotics and the occurrence of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) syndrome, a rare and serious adverse event characterized by eosinophilia and acute skin rash. Without early diagnosis, the syndrome can lead to complications or even death.
METHODS: In 2020, the Brazilian National Health Surveillance Agency (Anvisa) made available a system for reporting adverse drug events, called VigiMed. Reports of adverse events registered on this system between December 1, 2018 and December 31, 2022, were analyzed. Reporting odds ratio (ROR), together with the respective 95% confidence intervals (95% CI), was calculated as a measure of the association between antibiotics and DRESS syndrome.
RESULTS: A total of 160,101 reports of adverse drug events were analyzed, with 136 suspected cases of DRESS syndrome. Compared with other drugs, the following frequencies of suspected DRESS syndrome were observed for the use of any antibiotic (ROR: 4.8; 95% CI: 3.3-7.0), meropenem (ROR: 13.0; 95% CI: 8.0-21.0), vancomycin (ROR: 11.5; 95% CI: 7.4-17.6), ampicillin (ROR: 6.8; 95% CI: 2.1-21.8), amoxicillin (ROR: 4.7; 95% CI: 1.5-15.0), cefepime (ROR: 4.3; 95% CI: 1.3-13.6), piperacillin + tazobactam (ROR: 2.5; 95% CI: 1.1-5.8) and ceftriaxone (ROR: 2.4; 95% CI: 1.1-5.1). The ROR for DRESS syndrome and the use of oxacillin was 2.7 with a wide 95% CI (0.7-11.1).
CONCLUSIONS: An association was observed between reports of DRESS syndrome and the use of antibiotics, particularly those routinely used in a hospital setting. Although there is a potential risk of underreporting or unattributed causality, the information obtained in this study is valuable for the analysis of rare adverse reactions. Given the seriousness of the findings, further studies should be conducted to obtain more accurate information about this adverse reaction.
METHODS: In 2020, the Brazilian National Health Surveillance Agency (Anvisa) made available a system for reporting adverse drug events, called VigiMed. Reports of adverse events registered on this system between December 1, 2018 and December 31, 2022, were analyzed. Reporting odds ratio (ROR), together with the respective 95% confidence intervals (95% CI), was calculated as a measure of the association between antibiotics and DRESS syndrome.
RESULTS: A total of 160,101 reports of adverse drug events were analyzed, with 136 suspected cases of DRESS syndrome. Compared with other drugs, the following frequencies of suspected DRESS syndrome were observed for the use of any antibiotic (ROR: 4.8; 95% CI: 3.3-7.0), meropenem (ROR: 13.0; 95% CI: 8.0-21.0), vancomycin (ROR: 11.5; 95% CI: 7.4-17.6), ampicillin (ROR: 6.8; 95% CI: 2.1-21.8), amoxicillin (ROR: 4.7; 95% CI: 1.5-15.0), cefepime (ROR: 4.3; 95% CI: 1.3-13.6), piperacillin + tazobactam (ROR: 2.5; 95% CI: 1.1-5.8) and ceftriaxone (ROR: 2.4; 95% CI: 1.1-5.1). The ROR for DRESS syndrome and the use of oxacillin was 2.7 with a wide 95% CI (0.7-11.1).
CONCLUSIONS: An association was observed between reports of DRESS syndrome and the use of antibiotics, particularly those routinely used in a hospital setting. Although there is a potential risk of underreporting or unattributed causality, the information obtained in this study is valuable for the analysis of rare adverse reactions. Given the seriousness of the findings, further studies should be conducted to obtain more accurate information about this adverse reaction.