Adverse reactions related to proton pump inhibitors in pediatric population: an analysis of spontaneous reporting data.
Adverse drug reaction
label
pediatrics
proton pump inhibitors
seriousness
Journal
Expert opinion on drug safety
ISSN: 1744-764X
Titre abrégé: Expert Opin Drug Saf
Pays: England
ID NLM: 101163027
Informations de publication
Date de publication:
Jan 2022
Jan 2022
Historique:
pubmed:
9
9
2021
medline:
20
1
2022
entrez:
8
9
2021
Statut:
ppublish
Résumé
The use of proton pump inhibitors (PPIs) has increased in the last 10 years in children. Data regarding their safety profile are limited. The aim of this study was to analyze data from the Italian spontaneous reporting system (SRS) database to evaluate the incidence and characteristics of PPI-related adverse drug reactions (ADRs) in children. This was an observational, retrospective study analyzing PPI-related ADR reports in children in the Italian SRS database between January 1 Seventy spontaneous reports of ADRs related to PPIs were analyzed. Esomeprazole and lansoprazole caused the highest number of ADRs equally (27% respectively), and the most frequently reported ADRs presented with gastrointestinal (24%) and/or skin manifestations (21.3%). More than a half of PPI prescriptions were off label for pediatric population. Serious ADRs were 19 (27.1%). Serious ADRs were more frequent in reports presenting PPIs combined with other drugs in comparison to reports with PPI single therapies (p = 0.03). PPI-related ADRs in children are mostly not serious, and combination therapy seems to be associated with ADR seriousness.
Sections du résumé
BACKGROUND
BACKGROUND
The use of proton pump inhibitors (PPIs) has increased in the last 10 years in children. Data regarding their safety profile are limited. The aim of this study was to analyze data from the Italian spontaneous reporting system (SRS) database to evaluate the incidence and characteristics of PPI-related adverse drug reactions (ADRs) in children.
RESEARCH DESIGN AND METHODS
METHODS
This was an observational, retrospective study analyzing PPI-related ADR reports in children in the Italian SRS database between January 1
RESULTS
RESULTS
Seventy spontaneous reports of ADRs related to PPIs were analyzed. Esomeprazole and lansoprazole caused the highest number of ADRs equally (27% respectively), and the most frequently reported ADRs presented with gastrointestinal (24%) and/or skin manifestations (21.3%). More than a half of PPI prescriptions were off label for pediatric population. Serious ADRs were 19 (27.1%). Serious ADRs were more frequent in reports presenting PPIs combined with other drugs in comparison to reports with PPI single therapies (p = 0.03).
CONCLUSIONS
CONCLUSIONS
PPI-related ADRs in children are mostly not serious, and combination therapy seems to be associated with ADR seriousness.
Identifiants
pubmed: 34494498
doi: 10.1080/14740338.2021.1978975
doi:
Substances chimiques
Proton Pump Inhibitors
0
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM