Klinische Infektionskrankheiten: Open Access

Suspected Hy’s Law- Fast, but not That Fast!

Abstract

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.