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The safety of proton pump inhibitors in children with gastroesophageal reflux disease

Safe People

Organisation name

McGill University

Organisation sector

Academic Institute

Applicant name(s)

Samy Suissa - Chief Investigator - McGill UniversityKristian Filion - Corresponding Applicant - McGill UniversityClaire Lefebvre - Collaborator - University Of MontrealJoseph Delaney - Collaborator - University of Manitobapauline reynier - Collaborator - Sir Mortimer B Davis Jewish General HospitalReem Masarwa - Collaborator - McGill UniversityRobert Platt - Collaborator - McGill University

Safe Projects

Project ID

CPRD250

Lay summary

Children are an understudied and vulnerable population. Prescription drugs are often used outside the specifications described in their license in terms of age restrictions and reasons for use. Symptoms of gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD) are common during childhood and may affect up to 40% of infants and children. Due to the encouraging safety profile and wide use of proton pump inhibitors (PPIs) in adults, coupled with the high prevalence of GER problems in children, children are being increasingly prescribed this class of drugs.

Technical summary

The high prevalence of GER/GERD in children is becoming increasingly recognized. These conditions produce a variety of symptoms, including regurgitation, abdominal pain, and respiratory symptoms that can affect the quality of life of children and their parents. PPIs are acid suppressing drugs that are commonly prescribed for the management of GER/GERD among children. However, limited evidence is available regarding their effectiveness and safety among pediatric patients. A limited number of clinical trials have examined their safety; however, these studies were conducted in small numbers and only examined short-term outcomes.

Latest approval date

27/04/2021

Safe Data

Dataset(s) name

HES Admitted Patient Care

Safe Setting

Access type

Release