Monitoring the HePAtological TOXicity of Drugs (HePATOX)

Monitoring the HePAtological TOXicity of Drugs

Several drugs and chemotherapies seem to have an impact on the hepatological system. This study investigates reports of hepatological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Several drugs and chemotherapies seem to have an impact on the hepatological system and are responsible of a wide range of hepatological diseases and side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare hepatological side effects imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Inclusion Criteria:

• Case reported in the WHO's pharmacovigilance database till 04/02/2019

Exclusion Criteria:

• Chronology not compatible between the drug and the toxicity