Abstract
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.
Keywords
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Article info
Publication history
Published online: November 18, 2022
Accepted:
October 31,
2022
Received:
August 29,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
