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Citation |
Björnsson ES, Hoofnagle JH. Hepatology 2015; 63(2): 590-603. |
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Affiliation |
Liver Disease Research Branch, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Bethesda, MD. |
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Copyright |
(Copyright © 2015, John Wiley and Sons) |
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DOI |
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PMID |
26517184 |
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Abstract |
An important element in assessing causality in drug-induced liver injury is whether the implicated agent is known to cause hepatotoxicity. We classified drugs into categories based upon the numbers of published reports of convincingly documented, clinically apparent, idiosyncratic liver injury. Drugs described in the website" LiverTox" (http://livertox.nih.gov) were classified into 5 categories based upon the number of published cases: A: ≥ 50, B: ≥ 12 but <50, C: ≥ 4 but <12, D: 1-3, E: none. Case reports in category C and D were individually reanalyzed using the Roussel Uclaf Causality Assessment Method (RUCAM). Drugs with fatal cases or with rechallenge were noted. Among 671 individual drugs or closely related agents, 353 (53%) were considered convincingly linked to liver injury in published case reports; 48 (13%) were assigned to Category A, 76 (22%) B, 96 (27%) C and 126 (36%) D whereas 318/671 (47%) had no convincing case report of hepatoxicity in the literature, (Category E). Another 7 (2%) were direct hepatotoxins but only in high doses and placed in a separate Category (T). All except one in A have been available since 1999, 98% had at least one fatal case and 89% a positive rechallenge. In Category B, 54% had a fatal case and 41% a rechallenge. Drugs in Categories C and D less frequently had instances of fatal (23% and 7%) or rechallenge cases (26% and 11%). Language: en |