Spontaneous reporting of adverse reactions related to proton pump inhibitors.
Lansoprazole
Omeprazole
Seriousness
System organ class
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
05 2023
05 2023
Historique:
received:
29
08
2022
revised:
21
10
2022
accepted:
31
10
2022
medline:
1
5
2023
pubmed:
21
11
2022
entrez:
20
11
2022
Statut:
ppublish
Résumé
Proton pump inhibitors (PPIs) are widely prescribed in all age groups, and their use is increasing. However, their safety profile has been frequently questioned. The aim of this study was to analyze the characteristics of PPI-related adverse drug reactions (ADRs) reported to the Italian spontaneous reporting system (SRS) database and relative to an Italian region (Sicily). A 20-year observational, retrospective study was conducted, evaluating PPI-related ADR reports from Sicily between January 1st, 2001, and June 30th, 2021. The factors associated with ADR seriousness were investigated. A total of 148 spontaneous reports of ADRs related to PPIs were analyzed. Lansoprazole was the drug with the highest number of associated reports (30.87%). The most frequently reported ADRs were cutaneous (24.56%) and/or gastrointestinal manifestations (18.10%), the latter especially in the case of lansoprazole-related ADRs (p<0.006). The great majority of ADR reports were relative to on-label prescriptions. Serious ADRs were 39 (26.35%). Serious ADRs were more common in reports including omeprazole than in reports containing other PPIs (p<0.008) and in reports presenting PPIs combined with other drugs than in reports with PPI single therapies (p<0.001). Most PPI-related ADRs are non-serious. Omeprazole and combination therapy seem to be associated with ADR seriousness.
Sections du résumé
BACKGROUND
Proton pump inhibitors (PPIs) are widely prescribed in all age groups, and their use is increasing. However, their safety profile has been frequently questioned.
AIMS
The aim of this study was to analyze the characteristics of PPI-related adverse drug reactions (ADRs) reported to the Italian spontaneous reporting system (SRS) database and relative to an Italian region (Sicily).
METHODS
A 20-year observational, retrospective study was conducted, evaluating PPI-related ADR reports from Sicily between January 1st, 2001, and June 30th, 2021. The factors associated with ADR seriousness were investigated.
RESULTS
A total of 148 spontaneous reports of ADRs related to PPIs were analyzed. Lansoprazole was the drug with the highest number of associated reports (30.87%). The most frequently reported ADRs were cutaneous (24.56%) and/or gastrointestinal manifestations (18.10%), the latter especially in the case of lansoprazole-related ADRs (p<0.006). The great majority of ADR reports were relative to on-label prescriptions. Serious ADRs were 39 (26.35%). Serious ADRs were more common in reports including omeprazole than in reports containing other PPIs (p<0.008) and in reports presenting PPIs combined with other drugs than in reports with PPI single therapies (p<0.001).
CONCLUSION
Most PPI-related ADRs are non-serious. Omeprazole and combination therapy seem to be associated with ADR seriousness.
Identifiants
pubmed: 36404233
pii: S1590-8658(22)00780-0
doi: 10.1016/j.dld.2022.10.024
pii:
doi:
Substances chimiques
Proton Pump Inhibitors
0
Omeprazole
KG60484QX9
Lansoprazole
0K5C5T2QPG
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
595-600Informations de copyright
Copyright © 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of interest None declared.