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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Drugs susceptible to induce hepatological toxicities
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, France
Hepatological toxicities of drugs Identification and report of cases of hepatological toxicities associated with drugs.
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Causality assessment of reported hepatological toxicities events according to the WHO system
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the type of hepatoilogical toxicity depending on the category of drug
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the other immune related adverse events concomitant to the hepatological toxicity induced by drugs
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the drug-drug interactions associated with adverse events
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
Description of the population of patients having hepatological toxicity adverse event
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Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019