Long-term use of PPIs appears to be safe in children

Clinical Question

Is long-term therapy with proton pump inhibitors safe for children?

Bottom Line

Long-term proton pump inhibitor (PPI) therapy (median treatment duration = 35.2 months) appears to be safe for children. Serum gastrin levels remained elevated in nearly 75% of children, but there was no evidence of an increased risk of carcinoid tumor, abnormal vitamin B12 absorption, or any other concerning outcome. (LOE = 1b-)

Reference

Tolia V, Boyer K. Long-term proton pump inhibitor use in children: A retrospective review of safety. Dig Dis Sci 2008:53(2):385-93.  [PMID:17676398]

Study Design

Cohort (retrospective)

Funding

Unknown/not stated

Setting

Outpatient (specialty)

Synopsis

Concerns about the long-term use of PPI therapy in children include an increased risk of carcinoid tumors, rebound hypersecretion, atrophic gastritis, and enteric infection, as well as abnormal vitamin B12 absorption. These investigators retrospectively reviewed the medical records of all children (mean age = 7.5 years; range = 0.1 -17.6 years) consecutively evaluated for gastroesophageal reflux disease at a specialty gastroenterology outpatient clinic. Eligible patients (n = 117) included those receiving continuous PPI therapy for at least 1 year with a baseline gastric biopsy performed before the initiation of therapy. Complete follow-up with at least 1 repeat endoscopy occurred for 97% of children, for a mean treatment duration of 32 months to 47 months. The authors do not specifically state whether individuals assessing outcomes remained blind to the study hypothesis or individual drug therapy. No significant differences in symptom improvements were reported between various PPI types or dosing frequencies. The most frequently observed histologic findings during treatment included parietal cell hyperplasia and nonspecific gastritis. No precancerous hyperplasia was observed. Vitamin B12 levels and liver function test results remained in the normal range in all patients during the entire course of therapy. Above-normal serum gastrin levels were seen in 73% of children. The most frequent adverse events included diarrhea (5%) and constipation (4%).