Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center (Pediatry ADR)

CHU de Reims

Status: Completed

Conditions: Child With Adverse Drug Reactions

Treatments: Other: Adverse drug reaction

Study type: Observational

Funder types: Other

Identifiers

NCT03316014

2016Ao003

Details and patient eligibility

About

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

Full description

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.

Enrollment: 632 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

632 participants in 1 patient group

Adverse drug reaction

Description:

Children from 0 to 17 years inclusive with 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

Treatment:

Other: Adverse drug reaction