liver injury drug

PURPOSE Identifying drug-induced liver injury is a critical task in drug development and postapproval real-world care. Severe liver injury is identified by the liver chemistry threshold of alanine aminotransferase (ALT) >3× upper limit of normal (ULN) and bilirubin >2× ULN, termed Hy's law by the Food and Drug Administration. These thresholds require discontinuation of the causative drug and ar...

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Metabolic activation and inflammation reactions involved in carbamazepine-induced liver injury.

Journal: :Toxicological sciences : an official journal of the Society of Toxicology 2012

Satonori Higuchi Azusa Yano Shohei Takai Koichi Tsuneyama Tatsuki Fukami Miki Nakajima Tsuyoshi Yokoi

Drug-induced liver injury is a major safety concern in drug development and clinical pharmacotherapy; however, advances in the understanding of the mechanisms of drug-induced liver injury are hampered by the lack of animal models. Carbamazepine (CBZ) is a widely used antiepileptic agent. Although the drug is generally well tolerated, only a small number of patients prescribed CBZ develop severe...

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