Child With Adverse Drug Reactions Clinical Trial
Official title:
Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
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.
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