| アブストラクト | Eravacycline is a novel fluorocycline antibiotic approved for complicated intra-abdominal infections and hospital-acquired/ventilator-associated bacterial pneumonia. Its real-world adverse event profile and patterns of off-label use remain incompletely characterized. We conducted a comparative pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) covering 2014Q1-2025Q4. Eravacycline suspect cases (2019Q1-2025Q4) were compared with tigecycline, minocycline, and meropenem suspect cases. Serious outcome rates were compared using chi-square or Fisher's exact test. Disproportionality analysis used the Reporting Odds Ratio (ROR) with the pooled comparator reports as background reference. Two distinct definitions of off-label use were employed: reporter-coded MedDRA PT "off label use," and indication-based classification. All analyses are exploratory. A total of 158 eravacycline suspect cases were identified. Serious outcomes were observed in 67.1% of eravacycline cases, significantly lower than tigecycline (93.9%), minocycline (86.0%), and meropenem (97.4%), all p < 0.001. Twenty-three significant disproportionality signals were identified. The most clinically notable were a coagulopathic cluster - blood fibrinogen decreased (ROR 73.742, 95% CI 42.954-126.598; n = 16), lactic acidosis (ROR 57.803; n = 11), and hypertransaminasaemia (ROR 58.417; n = 10) - and pancreatitis (ROR 20.338; n = 8), not prominently described in the prescribing information. Indication-based off-label use accounted for 86.7% of cases (n = 137), predominantly for pulmonary Mycobacterium abscessus infection (17.7%). Quarterly reporting showed a significant upward trend (slope = 0.41 reports/quarter, R(2) = 0.256, p = 0.010). Eravacycline signals were observed for a lower reporting proportion of serious adverse outcomes compared with three active comparators. A distinctive coagulopathic and hepatic signal profile was identified, with pancreatitis as a potentially novel signal warranting prospective investigation. Off-label use, particularly for pulmonary Mycobacterium abscessus infection, predominates in real-world practice. These findings are hypothesis-generating and require validation in prospective, controlled studies. |
|---|
| ジャーナル名 | Naunyn-Schmiedeberg's archives of pharmacology |
|---|
| Pubmed追加日 | 2026/8/20 |
|---|
| 投稿者 | Chen, Yan; Xu, Yi; Hou, Feifei; Wang, Jianfeng |
|---|
| 組織名 | Department of General Practice, The First Affiliated Hospital of Zhejiang Chinese;Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou,;China.;Zhejiang Chinese Medical University, Hangzhou, China.;Taoyuan Community Health Service Center, Gongshu District, Hangzhou, Zhejiang,;People's Republic of China.;Department of Respiratory Diseases, The First Affiliated Hospital of Zhejiang;Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine),;Hangzhou, China. 2001m@163.com. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42618637/ |
|---|
