| アブストラクト | Labetalol is widely prescribed as a first-line antihypertensive in pregnancy; however, rare but potentially severe idiosyncratic hepatotoxicity has been reported, with a disproportionately strong reporting signal for liver injury relative to other beta-blockers. In this report, a fatal case is described in which mild initial symptoms rapidly progressed to fulminant hepatocellular injury and acute liver failure within days, underscoring the importance of early recognition of drug-induced liver injury and prompt discontinuation of labetalol. A PRISMA-guided systematic review of MEDLINE, Embase, CINAHL, Cochrane Library, PubMed, and Google Scholar (from inception to December 2025) identified 27 published case reports. Patients were predominantly female ( approximately 80%), and one-third were pregnant or postpartum. Latency ranged from 7 to 365 days (median approximately 60 days). The injury phenotype was consistently hepatocellular, often with autoimmune-like serologic or histologic features. Outcomes included full recovery in most ( approximately 75%), but also liver transplantation and death. In the FDA Adverse Event Reporting System (2020Q1-2025Q1), labetalol showed strong disproportionality signals for DILI (PRR 22.7, 95% CI 15.6-33.1; ROR 23.7, 95% CI 16.0-35.1; IC025 2.5) and autoimmune hepatitis (PRR 59.8, 95% CI 34.1-104.8; ROR 60.9, 95% CI 34.4-108.1; IC025 2.8), which persisted when restricted to other beta-blockers as comparators. Signals for acute hepatic failure and hyperbilirubinemia were elevated but less statistically robust. The available evidence is consistent with a clinically meaningful and biologically plausible association between labetalol and idiosyncratic hepatotoxicity, supporting heightened clinical awareness and further mechanistic and population-based study. |
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| ジャーナル名 | Journal of clinical pharmacology |
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| Pubmed追加日 | 2026/4/24 |
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| 投稿者 | Hendriksen, Emma D; Rieder, Michael; Urbantke, Elizabeth |
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| 組織名 | Department of Pharmacology, Schulich School of Medicine and Dentistry, University;of Western Ontario, London, Ontario, Canada.;Department of Pediatrics and Physiology, University of Western Ontario, London,;Ontario, Canada.;Office of the Chief Coroner of Ontario, Ontario, Canada. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42030085/ |
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