Drug‐Induced Liver Disease

Drug-induced hepatotoxicity is a frequent cause of acute liver injury. Few data on the epidemiology of drug-induced liver disease are available. Two main categories of drugs can produce liver disease. One group consists of intrinsic (predictable) drugs, whereas a second group consists of idiosyncratic (unpredictable) drugs. Drug reactions can be categorized broadly as hepatocellular, cholestatic, or mixed, but these are only general terms and do not apply in all circumstances. Intravenous N-acetylcysteine may be considered for treatment of drug-induced liver injury in those experiencing early-stage hepatic failure. Bromfenac and troglitazone were both withdrawn because of severe and fatal liver injury. There are important lessons to be learned from each one, illustrating the difficult issues surrounding drug-induced liver injury. Drug development is divided into three stages: initial research and development, clinical testing for new drug application (NDA), and the postmarketing experience.