Coagulation dysfunction events associated with novel tetracycline-class drugs: a disproportionality and Bayesian analysis based on the FAERS database.

Introduction: In contemporary clinical practice, novel tetracycline-class antimicrobial agents have been increasingly utilized due to their favorable pharmacological profiles. However, the potential association between novel tetracycline-class drugs and coagulation dysfunction is relatively underreported in the literature. This study utilizes the FDA Adverse Event Reporting System (FAERS) to identify and analyze risk signals for coagulation disorders associated with three commonly used the novel tetracyclines in clinical practice. The findings are expected to provide valuable references for clinicians in the targeted monitoring of adverse drug reactions. Methods: Coagulation dysfunction reports associated with the novel tetracycline-class drugs, submitted to the FDA Adverse Event Reporting System (FAERS) from January 2004 to December 2024, were collected. Data mining was performed using the ROR, PRR, BCPNN, and MGPS. All data extraction was conducted using R software (version 4.4.2).It should be noted that FAERS is a spontaneous reporting system without exposure denominators and is subject to reporting bias and confounding factors. Results: A total of 346 coagulation dysfunction reports with the novel tetracycline-class drugs as suspected drugs were screened, including 327 for tigecycline, 6 for omadacycline, and 13 for eravacycline. Disproportionate reporting signals of coagulation dysfunction were detected for both tigecycline and eravacycline, with tigecycline showing the strongest signal [ROR = 46.85 (42.29-51.91)]. Subgroup analyses by age, gender, and dosage revealed a higher proportion of male patients receiving tigecycline and eravacycline. while tigecycline and eravacycline exhibited a stronger disproportionate reporting signal in male patients over 65 years old. Omadacycline showed stronger disproportionate reporting signal at a daily dose of 100 mg. The peak onset time for omadacycline was consistently 9 days. However, all subgroup findings for omadacycline and eravacycline should be interpreted with extreme caution due to the limited number of reports. These observations are considered exploratory rather than confirmatory. Conclusion: Disproportionality analysis identified prominent signals of coagulation dysfunction signals associated with tigecycline and eravacycline. Distinctive reporting patterns of coagulation abnormalities were observed across the three novel tetracyclines, with visible discrepancies in patient age, gender, therapeutic indications, daily dosage, clinical outcomes, and adverse event onset time. Based on the above findings, clinicians should maintain high vigilance against the potential coagulation abnormalities induced by novel tetracyclines, and implement standardized and rational therapeutic drug monitoring during clinical medication practice.