Prospective identification and causality evaluation of suspected adverse drug reactions in neonates.
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ABSTRACT:
SUBMITTER: Roberts EK
PROVIDER: S-EPMC9328662 | biostudies-literature | 2021 Mar
REPOSITORIES: biostudies-literature
Publications
Prospective identification and causality evaluation of suspected adverse drug reactions in neonates.
Roberts Eve K EK Hawcutt Daniel B DB Turner Mark A MA
British journal of clinical pharmacology 20200907 3
Neonates experience adverse drug reactions (ADRs), but under-reporting of suspected ADRs to national spontaneous reporting schemes in this population is particularly high. A prospective observational study collected suspected neonatal ADRs at a tertiary neonatal unit. Cases were analysed for causality by six assessors using three existing methods. Sixty-three suspected ADR cases were identified in 35/193 neonates (18.1%). The proportion of suspected ADRs where the drug was prescribed "off-label" ...[more]
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