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  • Comparable paediatric safety profiles of proton pump inhibitors and histamine-2 receptor antagonists

Hospitalisation rates for predefined safety outcomes (gastroenteritis, convulsion/seizure, pneumonia, thrombocytopenia, acute interstitial nephritis, angioneurotic oedema and failure to thrive) were low and mostly similar in paediatric first-time users of proton pump inhibitors (PPIs) and of histamine-2 receptor antagonists (H2RAs). Significant differences were observed only for failure to thrive, with an increased risk in patients using esomeprazole compared to other PPIs or H2RAs, potentially related to the severity of the indication (gastroesophageal reflux disease) rather than to the exposure. This was concluded in a study recently published in Current Medical Research and Opinion. In this study the occurrence of various predefined safety outcomes was assessed in children first dispensed esomeprazole, a PPI other than esomeprazole or an H2RA. Data for the study was obtained from the Out-patient Pharmacy Database and Hospitalisation Database from the PHARMO Database Network, with additional information collected from hospital discharge letters. Findings suggest that the safety profile of PPIs and H2RAs are similar in paediatric populations.

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