| アブストラクト | AIM: Avacopan is an oral C5a receptor antagonist approved for anti-neutrophil cytoplasmic antibody-associated vasculitis. Recent post-marketing safety information has raised concern regarding serious hepatobiliary injury, including vanishing bile duct syndrome (VBDS). We compared Japanese and FAERS post-marketing reporting profiles for avacopan-associated adverse events. METHODS: FAERS public dashboard data and PMDA CSV data downloaded in May 2026 were searched using Japanese and English avacopan/Tavneos terms and analyzed at the case report and adverse-event/preferred-term row levels. FAERS Public Dashboard aggregate data were searched using the avacopan generic-name listing as the primary definition and the Tavneos product-name listing as a sensitivity definition. RESULTS: PMDA/JADER contained 397 avacopan-related reports and 744 adverse-event/preferred-term rows. FAERS contained 5770 reports in the avacopan generic-name listing and 5216 reports in the Tavneos product-name listing. Hepatobiliary preferred terms were prominent in PMDA/JADER, including hepatic function abnormal (n = 86), liver disorder (n = 44), drug-induced liver injury (n = 40), and VBDS (n = 29). Among PMDA/JADER VBDS reports with available dates, the median time to onset was 44.0 days (interquartile range, 39.5-52.0). CONCLUSIONS: Post-marketing reports of avacopan-associated hepatobiliary injury, including VBDS, warrant clinical attention, particularly during the early treatment period. PMDA/JADER and FAERS findings should be interpreted as differences in reporting profiles rather than direct comparisons of incidence or risk. |
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| ジャーナル名 | Hepatology research : the official journal of the Japan Society of Hepatology |
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| Pubmed追加日 | 2026/7/15 |
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| 投稿者 | Kamimura, Hiroteru; Miyazawa, Makoto; Kaneko, Shota; Uesawa, Yoshihiro; Kobayashi, Daisuke; Yamamoto, Suguru; Terai, Shuji |
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| 組織名 | Division of Gastroenterology and Hepatology, Niigata University Graduate School;of Medicine, Dentistry and Health Sciences, Niigata, Japan.;Division of Pharmacy, Niigata University Medical & Dental Hospital, Niigata,;Japan.;Department of Medical Molecular Informatics, Meiji Pharmaceutical University,;Tokyo, Japan.;Division of Clinical Nephrology and Rheumatology, Kidney Research Center, Niigata;University Graduate School of Medicine, Dentistry and Health Sciences, Niigata, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42456043/ |
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