Spontaneous Adverse Drug Reaction Reports for Neonates and Infants in the UK 2001 ‐2010: Content and Utility analysis

ConclusionsThe frequency of YC reports for those <2 years is low, neonates are poorly represented, and recording of gestational age is poor. With the exception of vaccinations, spontaneous reports alone are not currently generating the data required, and important safety messages from the regulator do not match reporting patterns. Additional reporting strategies are required to improve the quantity and quality of suspected ADR data in young children.

Source: British Journal of Clinical Pharmacology - August 31, 2016 Category: Drugs & Pharmacology Authors: Daniel B. Hawcutt, Nicki ‐Jayne Russell, Hannah Maqsood, Koushan Kouranloo, Simon Gomberg, Catriona Waitt, Andrew Sharp, Andrew Riordan, Mark A. Turner Tags: PAEDIATRIC CLINICAL PHARMACOLOGY Source Type: research