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Safety of Proton Pump Inhibitor in Paediatrics: A Study Based on EudraVigilance Data
Greta Santi Laurini1, Victoria Nikitina1, Nicola Montanaro2
1Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
Insights
Proton pump inhibitor (PPI) use in children is rising, with studies showing gastrointestinal issues as common adverse drug reactions (ADRs). A significant proportion of serious ADRs and rare severe skin reactions were also reported in paediatric patients.
Area of Science:
- Pediatric pharmacology
- Drug safety and pharmacovigilance
- Gastroenterology
Background:
- Increased use of proton pump inhibitors (PPIs) in children despite limited approvals.
- Growing concerns regarding the safety profile of PPIs in pediatric populations, including allergy risks.
Purpose of the Study:
- To investigate suspected adverse drug reactions (ADRs) associated with PPI use in children (0-11 years).
- To provide evidence on the safety of PPIs in pediatric clinical practice.
Main Methods:
- Analysis of 1389 suspected ADR reports for PPIs in children aged 0-11 years from EudraVigilance (2003-2022).
- Descriptive analysis of reported ADRs and allergic conditions.
- Case-non-case analysis using reporting odds ratio (ROR) to identify significant associations.
Main Results:
- Gastrointestinal disorders were the most frequent ADRs, with vomiting being common.
- Omeprazole was linked to choking and pneumonia; esomeprazole to gastrointestinal disorder and constipation.
- A high percentage (75.8%) of reports involved serious outcomes, including rare severe cutaneous reactions like Stevens-Johnson syndrome.
Conclusions:
- Paediatric PPI use commonly results in gastrointestinal ADRs, aligning with product labeling.
- A notable proportion of serious ADRs and some severe cutaneous adverse reactions were observed in children.
- Further vigilance is warranted for PPI safety in pediatric populations.
Background And Objectives:
Despite limited paediatric approvals, the use of proton pump inhibitors (PPIs) among children has increased in recent years, and concerns have arisen about their safety, including the risk of allergies. To provide additional evidence on the paediatric safety of PPIs, we performed a study on suspected adverse drug reactions (ADRs) in clinical practice.
Methods:
We retrieved from EudraVigilance reports of suspected ADRs for PPIs in the age class 0-11 years in the period 2003-2022. Most reported ADRs and allergic conditions were evaluated by descriptive analysis. A case-non-case analysis was performed using reporting odds ratio (ROR) with a 95% confidence interval (CI). Chi-square or Fisher's exact tests were used to detect differences in reporting rates.
Results:
A total of 1389 reports and 4157 suspected ADRs were analysed. Most reports involved omeprazole (46.9%) and esomeprazole (27.3%), and 75.8% concerned serious outcomes. Gastrointestinal disorders were among the most common suspected ADRs, with vomiting being the most frequently reported (2.3%). Among allergic conditions, there were six cases of toxic epidermal necrolysis, five of Stevens-Johnson syndrome and four of drug reaction with eosinophilia and systemic symptoms. Statistically significant reactions for omeprazole were choking (ROR 5.54; 95% CI, 1.04-29.56) and pneumonia (3.61; 1.41-9.20), while for esomeprazole gastrointestinal disorder (7.57; 1.18-48.60) and constipation (4.74; 2.25-9.98).
Conclusions:
Most common suspected ADRs reported with paediatric PPI use in Europe were gastrointestinal disorders, consistent with the safety profile in the product license. However, a high proportion of serious ADRs and few cases of severe cutaneous adverse reactions were reported.
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