Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Groupe Hospitalier Pitie-Salpetriere2,700 enrolled

Overview

Several drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, 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 metabolic system and are responsible of a wide range of metabolical side effects such as hyperammonemia. 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 metabolic side effects imputed to drugs in particular hyperammonemia. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Study Type

OBSERVATIONAL

Enrollment

2,700

Conditions

Hyperammonemia Metabolic Disease Adverse Drug Event Drug Toxicity

Interventions

Drugs inducing hyperammonemiaDRUG

Drugs susceptible to induce metabolic toxicities such as hyperammonemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Case reported in the WHO's pharmacovigilance database till 01/05/2019 Exclusion Criteria: * Chronology not compatible between the drug and the toxicity

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, France

Outcomes

Primary Outcomes

Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.