International report advises on liver injuries

The report about the management of drug-induced liver injuries, released on June 16 by the Council for International Organizations of Medical Sciences (CIOMS), is now available for download. In addition to its guidelines, the material provides a global perspective on drug-induced liver injuries detection, the risk assessment and management of drug development, as well as post-market monitoring of products, focusing on liver damage caused by drugs. 

Drug-induced liver injurie is a major clinical and regulatory challenge. This happens because, in many cases, the hepatotoxicity potential (likelihood of causing liver damage) can only be assessed in post-marketing, only after the product has already being sold and used. These types of injuries are the most frequent reasons for the withdrawal of drugs from the market and for changes in the labeling. 

The preparation of the report started in 2017. Anvisa, which was represented by Mônica Soares, took part in the publication, together with other international institutions, such as the Food and Drug Administration - FDA , the European Medicines Agency (EMA) and the World Health Organization (WHO), among others.  

About CIOMS 

The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization created by WHO and UNESCO in 1949. Its mission is to promote public health through guidance on health research including ethics, medical product development and safety. The organization represents a substantial proportion of the global biomedical scientific community through its member organizations.   

Check here the full text: 

Drug-Induced Liver Injury (DILI): Current status and future directions for drug development and the post-market setting.