Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center

CHU de Reims632 enrolled

Overview

Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics

Pediatry aged under 18 years accounted for around 22% of the French general population. Data regarding drug safety from clinical trials are insufficient in this population. Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics.

Study Type

OBSERVATIONAL

Enrollment

632

Conditions

Child With Adverse Drug Reactions

Interventions

Adverse drug reactionOTHER

description of the adverse drug reactions (ADR) and the drugs involved in pediatrics

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

inclusion criteria: * Children from 0 to 17 years inclusive * Who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne exclusion criteria: * none

Outcomes

Primary Outcomes

the different type of ADR

Time frame: 30 years

Data from ClinicalTrials.gov

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