アブストラクト | BACKGROUND: Metronidazole (MNZ) can be administered for various infections. The impact of comorbidities/concomitant drugs on MNZ-induced central nervous system (CNS) disorders remains unclear. RESEARCH DESIGN AND METHODS: We assessed the risk of metronidazole-related CNS disorders using the Japan Adverse Drug Event Report (JADER, May 2023) and the US Food and Drug Administration Adverse Event Reporting System (FAERS, Q1 2023), excluding comorbidities/concomitant drugs. Clonazepam and diazepam were evaluated as potential prophylactics based on the efficacy of benzodiazepines for MNZ-related CNS disorders. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated. Additionally, sensitivity analysis by sex and age was conducted. RESULTS: The ROR (95% CI) of CNS disorders associated with MNZ in JADER and FAERS were 3.16 (2.69-3.72) and 1.69 (1.64-1.73), respectively. MNZ was significantly related to CNS disorders after excluding comorbidities (brain/spinal cord or liver abscesses) and concomitant drugs (glucocorticoids, antiepileptic, antiparkinson, and schizophrenia drugs). In sensitivity analysis, MNZ was significantly related to CNS disorders, despite sex and age. The ROR in the concomitant with clonazepam (CZP) was 0.70 (0.53-0.92) in FAERS. CONCLUSION: MNZ may be associated with CNS disorders, even if comorbidities/concomitant drugs that are potential risk factors for CNS disorders are excluded. Additionally, CZP may suppress CNS disorders. |
ジャーナル名 | Expert opinion on drug safety |
Pubmed追加日 | 2025/3/31 |
投稿者 | Takada, Keisuke; Enoki, Yuki; Samura, Masaru; Igarashi, Yuki; Taguchi, Kazuaki; Tanikawa, Koji; Matsumoto, Kazuaki |
組織名 | Division of Pharmacodynamics, Keio University Faculty of Pharmacy, Tokyo, Japan.;Department of Pharmacy, Yokohama General Hospital, Yokohama city, Kanagawa,;Japan.;Faculty of Pharmaceutical Sciences, Teikyo Heisei University, Tokyo, Japan. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40159088/ |