Suspected fatal adverse drug reaction in children
This prospective study ( June 2002 to June 2003) intended to document whether fatal adverse drug reactions (ADRs) were a problem in children in the UK. At the time of this study, it was possible that there may have been under-reporting of suspected adverse drug reactions (ADRs) in children. Medicines in children were frequently prescribed “off-label” and therefore had not been formally evaluated for safety and efficacy in that age group. It was hoped that this prospective study would, for the first time, allow the documentation of whether fatal adverse drug reactions were a significant problem in children.
Lead investigator
Professor T Stephenson
About the study
The Yellow Card Scheme, set up in 1964 and administered by the Medicines and Healthcare products Regulatory Agency
(MHRA), is the UK’s spontaneous reporting scheme and is the mainstay of drug safety monitoring in the UK.
At the time of this study, it was possible that there may have been under-reporting of suspected adverse drug reactions (ADRs) in children. Medicines in children were frequently prescribed “off-label” and therefore had not been formally evaluated for safety and efficacy in that age group. It was particularly important to report and detect potential drug safety issues in children. It was hoped that this prospective study would, for the first time, allow the documentation of whether fatal adverse drug reactions were a significant problem in children.
Duration
June 2002 – June 2003
Published papers
BPSU 18th Annual report 2003 -2004
Support group