| アブストラクト | OBJECTIVE: Brexanolone (Zulresso(R)) that was approved for the USA in March 2019 is indicated for the treatment of postpartum depression (PPD), but information on adverse drug reactions (ADRs) associated with its use is limited. The main aim of this study was to explore the postmarketing safety profile of brexanolone. METHODS: In our case/non-case pharmacovigilance study based on the FDA Adverse Event Reporting System (FAERS), the reporting odds ratio and information component with 95% confidence intervals were estimated as measures of disproportionate reporting. Primary disproportionality analyses were performed by comparing brexanolone with all other drugs or selective serotonin reuptake inhibitors (SSRIs). Sensitivity analyses were performed on a subset of perinatal depression. RESULTS: We identified 267 cases using brexanolone. Brexanolone was reported as a primary or secondary suspect drug in most cases (n = 260, 97.38%). Of the total brexanolone cases, positive dechallenge and discontinuation accounted for 12.36% (n = 33) and 26.22% (n = 70), respectively. Serious outcomes were reported in 11.61% (n = 31) patients. Compared to all the other drugs or SSRIs within the same time window, the reporting risks of brexanolone were mainly from psychiatric and nervous systems. Sensitivity analyses indicated that these significant disproportionalities were mostly retained. CONCLUSION: Our pharmacovigilance analysis showed a high reporting frequency of psychiatric and nervous system ADRs associated with the use of brexanolone. In additional prospective research, these signals urgently need to be clarified. |
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| ジャーナル名 | Archives of women's mental health |
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| 投稿日 | 2023/10/13 |
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| 投稿者 | Zhang, Meilian; Xie, Wenhuo; Li, Jianbin; Zheng, Jiaping; Zhou, Yu |
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| 組織名 | Department of Ultrasound, Fujian Maternity and Child Health Hospital, College of;Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical;University, Fuzhou, China.;Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy,;Fujian Medical University, Fuzhou, China.;Department of Rehabilitation Medicine, School of Health, Fujian Medical;University, Fuzhou, China. zhengjp@fjmu.edu.cn.;Fujian Medical University, Fuzhou, China. cfjsczy@fjmu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37831172/ |
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