Causality assessment of drug-induced liver injury. Hepatology Working Group.

None of the various methods for drug reaction assessment has been adapted to the well-defined damage of a specific organ. There are disagreements between the parties involved in this issue: practitioners, and experts in drug surveillance either in regulatory agencies or in the pharmaceutical industry. Consensus Meetings were therefore organized in order to answer the three basic questions related to the diagnosis of drug-induced liver injury: (a) is the liver involved? (b) what chronological and clinical criteria suggest a drug-induced reaction? (c) can non-drug-related causes be excluded? On the basis of the method for drug reaction assessment used in France, we describe criteria adapted to the case of acute cytolytic hepatitis, which constitutes only one aspect of the task of the Hepatology Working Group.