Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001-2010: content and utility analysis.

ABSTRACT:

Aims

The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect 'suspected' adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged <2 years.

Methods

Data on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA.

Results

For infants age <2 years, 3496 suspected ADRs were reported using YC (paternal medication pre-conception n = 3, transplacental n = 246, transmammary n = 30, neonates n = 97, infant n = 477, and vaccinations n = 2673), averaging 0.96 YC per day. There was a male preponderance (male 49.1%, female 44.4%, unknown 6.5%), and only 34 (1.0%) of YC reports stated a

SUBMITTER: Hawcutt DB 

PROVIDER: S-EPMC5099553 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature