El potencial hepatotoxico de un fármaco (descarga el archivo aquí)

Permite identificar por orden alfabético el principio activo del que se quiere conocer el potencial tóxico.

Drugs associated with hepatotoxicity (download the file)

We develop an updated comprehensive list of drugs implicated as causes of DILI and/or drug-induced acute liver failure (ALF) based on well-vetted or adjudicated DILI cases, coupled with the reporting frequency information in the WHO database.  

In this international collaborative work, we combined lists of :  

1) Drugs adjudicated as causes of DILI by the study groups in Spain, Sweden, and the US,

2) Drugs implicated as causes of ALF by the study groups in these three countries, and

3) Drugs which have been subjected to serious regulatory actions due to their hepatotoxicity in Europe or the US.  

The information was provided from the leading DILI/ALF study groups in the US and Europe and sought using published literature or other public domains including the websites of the regulatory agencies.  Data synthesis: We combined all the drug lists from the different sources, yielding total 385 pharmaceuticals.

Drugs were classified into three groups:  

1) Drugs identified at the three DILI registries using a standardized causality assessment tool,

2) Drugs implicated as causes of drug-induced ALF at six different studies/study groups with and without using a standardized causality assessment tool, and

3) Drug suspended or withdrawn due to their hepatotoxicity in the US or Europe. Drugs were then described for differences among the different data sources and their reporting frequency of liver events with different severity in the WHO global individual case safety report (ICSR) database system.

Conclusion: We believe the developed list in this project with the gathered information on ‘degrees’ of hepatotoxicity will aid in causality assessment and clinical diagnosis of DILI and facilitate future research on DILI.  

Acknowledgements 

This drug list was developed in the international collaboration with experts in various groups dedicated to the fields of drug safety and drug induced liver injury. A paper including a part of the information presented on this web site has been published at Drug Safety[33(6):503-522, 2010].

Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work.
Suzuki A, Andrade RJ, Bjornsson E, Lucena MI, Lee WM, Yuen NA, Hunt CM, Freston JW.Division of Gastroenterology, Duke University, Durham, North Carolina 27710, USA. This email address is being protected from spambots. You need JavaScript enabled to view it.


We also would like to acknowledge with our respects all the participating centers and contributors in the Spanish Group for the Study of Drug-induced Liver Disease and the American Groups, Acute Liver Failure Study Group and Drug Induced Liver Injury Network, who made significant contributions building the essential foundation of this project and to thank the GlaxsoSmithKlein Hepatotoxicity Board members for their expertise and helpful suggestions on this project.  

This work has been partially funded by a research grant from the Spanish Medicine Agency, Fondo de Investigacion Sanitaria FIS PI 07/0980 and EC07/90910. CIBERehd is funded by Instituto de Salud Carlos III. The Acute Liver Failure Study Group is funded by NIH Grant U-01 DK058369.