Adverse drug reactions may be under-reported in young children

A new study reveals that adverse drug reactions in newborns and infants may be under-reported.

For the study, investigators analyzed 2001-2010 information from the UK Medicines and Healthcare products Regulatory Agency, which runs a national spontaneous reporting system to collect suspected data.

The researchers found that spontaneous reports alone are not currently generating required data, and important safety messages from the regulator do not match reporting patterns. Additional reporting strategies will be required to improve the quantity and quality of information on suspected adverse drug reactions in .

"The UK set up the first system in the world to report adverse drug reactions, the Yellow Card Scheme, over 50 years ago. It has helped improve the safety of drugs immensely by identifying adverse drug reactions, and continues to be valuable today," said Dr. Daniel Hawcutt, lead author British Journal of Clinical Pharmacology study. "This research shows that for newborn babies and infants, the spontaneous reporting of adverse drug reactions may not be enough, and additional systems to seek out and report adverse are required."


Explore further

Harms reporting in trials of orlistat

More information: Daniel B. Hawcutt et al. Spontaneous Adverse Drug Reaction Reports for Neonates and Infants in the UK 2001-2010: Content and Utility analysis, British Journal of Clinical Pharmacology (2016). DOI: 10.1111/bcp.13067
Provided by Wiley
Citation: Adverse drug reactions may be under-reported in young children (2016, September 7) retrieved 16 October 2019 from https://medicalxpress.com/news/2016-09-adverse-drug-reactions-under-reported-young.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
2 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more