Drug-induced liver injury in clinical trials: as rare as hens' teeth.
Severe drug-induced liver injury is a relatively rare but important public health problem. Extrapolating the incidence of this problem from clinical treatment trials is confounded by a number of issues, including the relatively small size of clinical trials, exclusion criteria for study participation, and active surveillance for liver injury. Advances in understanding the pathogenesis of drug-induced liver injury, as well as its prevention and treatment, will likely require the identification and careful characterization of severe cases in the post-marketing, "real-world" setting as part of a concerted, multi-center, well-orchestrated effort. The Drug-Induced Liver Injury Network (DILIN) represents one example of such an effort.
Timothy J
TJ
Davern
Naga
N
Chalasani
D056486:Chemical and Drug Induced Liver Injury; D002986:Clinical Trials as Topic; D004008:Diclofenac / Q000009:adverse effects* / Q000627:therapeutic use; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D015994:Incidence; D008107:Liver Diseases / Q000453:epidemiology* / Q000473:pathology; D008111:Liver Function Tests; D008297:Male; D035583:Rare Diseases; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate
D004008:Diclofenac