Drug-Related Hepatotoxicity

Given its rarity, drug-related hepatotoxicity may not be seen during the initial clinical trials of a new medication. After approval, when many more patients are exposed, toxic effects that are very infrequent may emerge. This review explains the difficulties in identifying the cause of hepatotoxic effects in such situations and provides clinical guidance with regard to the detection, evaluation, and possible prevention of drug-related hepatotoxicity. This review explains the difficulties in identifying the cause of hepatotoxic effects and provides clinical guidance with regard to the detection, evaluation, and possible prevention of drug-related hepatotoxicity. In this review, we define hepatotoxicity as injury to the liver that is associated with impaired liver function caused by exposure to a drug or another noninfectious agent. The distinction between injury and function is important, because it is mainly when function is impaired that symptoms and clinically significant disease follow. We are especially concerned with serious drug-related hepatotoxicity that is disabling or life-threatening or that requires hospitalization. Although drug-related hepatotoxicity is uncommon — for many drugs, the reported incidence is between 1 in 10,000 and 1 in 100,000 patients 1 — its true incidence is difficult to determine. The numbers . . .