Medicinal products are an important cause of liver injury, and Drug-Induced Liver Injury (DILI) is one of the leading causes of acute liver failure worldwide. On this page you will find links to resoucres regarding DILI and related pharmacovigilance activities. This includes links to working groups, guidelines, videos, as well as links to external resources.

We are continually updating this page so please check back often! If you have any tools, other resources or items of interest that you believe would be helpful for others and that you would like to share with members, please let us know, either as a blog, in one of the discussion groups, or email a site co-ordinator directly. 


 

Council for International Organizations of Medical Sciences (CIOMS)

DILI Working Group
CIOMS launched a DILI Working Group in 2017 in order to address the current knowledge and practice gaps related to drug-induced liver injury (DILI). The group formulates pragmatic, consensus-based recommendations to address these issues. The CIOMS Consensus report on DILI was published in June 2020 and provides the current status of DILI and future directions for drug development and the post-market setting.

CIOMS Consensus Report on Drug-Induced Liver Injury - Webinar
CIOMS/CoRE-Duke NUS Webinar, held 20th July 2020. This webinar brings together leading DILI experts from regulatory authorities, the pharmaceutical industry and academia as they introduce the consensus report of the Council for International Organizations of Medical Sciences (CIOMS) DILI Working Group. The report provides a critical framework and essential tools to detect, diagnose and manage DILI during drug development and post-marketing. Presentation slides available here.

 

Food and Drug Administration (FDA)

Drug-Induced Liver Injury: Premarketing Clinical Evaluation
This guidance document intends to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug to cause severe liver injury. In particular, the guidance addresses how laboratory measurements that signal the potential for such drug-induced liver injury (DILI) can be obtained and evaluated during drug development.

Drug Induced Liver Injury Rank (DILIrank) Dataset
DILIrank consists of 1,036 FDA-approved drugs that are divided into four classes according to their potential for causing drug-induced liver injury (DILI). The DILI classification is derived from analyzing the hepatotoxic descriptions presented in the FDA-approved drug labeling documents and assessing causality evidence in literature.

 

Prospective European Drug-Induced Liver Injury Network (PRO-EURO DILI Network)

PRO-EURO DILI Network
The PRO-EURO DILI Network aims to set up a European-wide interdisciplinary co-operative network of stakeholders in the DILI field (including scientists, clinicians, regulatory authorities, Small and Medium Enterprises (SMEs) and industry partners). The Network has of five Working Groups, each with an area of focus:

 

European Association for the Study of the Liver (EASL)

Drug-Induced Liver Injury EASL Guideline
These Clinical Practice Guidelines summarize the available evidence on risk factors, diagnosis, management and risk minimization strategies for drug-induced liver jury.

Liver Tree
Access educational materials, eLearning activities, accredited live webinar sessions with polls and chat on EASL's digital library and hybrid virtual event platform. Here we link to Liver Tree's DILI resources, which includes webcasts, presentation slides and e-posters and can be clasified by subtopic, contributor and content type. Liver Tree is also available as an app. 

 

Drug-induced Liver Injury Network (DILIN)

Drug Induced Liver Injury Network
DILIN was established by The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to collect and analyze cases of severe liver injury caused by prescription drugs, over-the-counter drugs, and alternative medicines such as herbal products and supplements. The network is currently conducting two registry studies which are open for participation by any interested individuals.

 

IQ Consortium Drug-Induced Liver Injury Initiative (IQ-DILI)

IQ Consortium Drug-Induced Liver Injury Initiative
The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) endorsed the establishment of a DILI initiative in June 2016. The industry-led IQ-DILI Initiative is focused on defining the best practices for the detection, monitoring, management, and prevention of DILI in clinical trials and post-marketing pharmacovigilance programs. Here they share thier recent updates, working group activities and publications