Liga Ulmane, John Riefler, Maxim Kosov and Maxim Belotserkovsky
Drug-induced liver injury (DILI) is a major concern in clinical studies as well as in post-marketing surveillance. Several anti-infective drugs had development discontinued due to serious hepatic events- acute liver failure, including liver transplantation or death. The diagnosis of drug-induced liver injury necessitates an initial high degree of suspicion, based on circumstantial evidence. It is a step-by-step process of exclusion. Consequently, a patient in a clinical trial who experiences elevated LFTs that meet Hy’s Law criteria should have causes other than study drug carefully excluded.
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