Participants at the first meeting of the Working Group, Geneva 27-28 April 2017.
Working Group on Drug Induced Liver Injury
In 2017, CIOMS has launched a Working Group (WG) composed of key stakeholders including regulators, academia and industry partners to address the present knowledge and practice gaps related to drug induced liver injury (DILI) in order to formulate pragmatic consensus-based recommendations to address the outstanding issues listed below. Furthermore, collaborative efforts aimed at capitalizing on existing initiatives will also be a part of the WG in order to provide output that is as comprehensive as possible.
The incidence of drug induced liver injury (DILI) is a growing challenge because of the ever increasing number of drugs used in medical care. It is responsible for more than 10% of all cases of acute liver failure posing a major clinical and regulatory challenge. In a recent and well-executed population-based study, the crude annual incidence of DILI was 19.1 cases per 100,000 persons (95% CI, 1.54-23.3). In many instances, the hepatotoxic potential of a drug can only be recognized postmarketing and DILI is one of the most frequent reasons for marketed drug withdrawal and modification of labelling. The clinical pattern of DILI is diverse and can mimic almost any form of liver disease, ranging from asymptomatic elevation in aminotransferases to severe disease such as cirrhosis or acute hepatitis leading to acute liver failure, making it difficult for an easy and early diagnosis. It remains largely unpredictable and is not amenable to efficient preventive measures. Being an important cause of mortality and liver transplantation, and a leading cause of attrition in drug development DILI remains a public health issue of great importance which needs additional international consensus guidance.
11 - 13 April 2018
13th Meeting of the Implementation Working Group on MedDRA
14 December 2017