FDA Approves Nexium for Children Ages 1–11 with Gastroesophageal Reflux Disease

Background

The US Food and Drug Administration has approved esomeprazole magnesium (Nexium) for short-term use in children ages 1–11 years for the treatment of gastroesophageal reflux disease (GERD). The proton pump inhibitor is now available in two paediatric-appropriate formulations — a delayed-release capsule and an oral liquid — expanding options for a population that previously had limited approved pharmacologic choices for this common condition.

“This approval provides important information for appropriate dosing for children ages 1–11 years with GERD,” said Julie Beitz, MD, director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. “Children prescribed this drug should be monitored by their physicians for any adverse drug reactions.”

Approval Snapshot

How the Approval Was Supported

The FDA based this approval on extrapolation of efficacy data from previous adult GERD studies to the paediatric population, combined with dedicated paediatric safety and pharmacokinetic studies. In the pivotal paediatric study, 109 patients ages 1–11 diagnosed with GERD received once-daily esomeprazole magnesium for up to 8 weeks to evaluate safety and tolerability. Most patients demonstrated healing of esophageal erosions after the 8-week treatment course.

Approved Dosing by Age Group

Dosing shown reflects the FDA's approved labeling at the time of this report; always confirm current prescribing information before use.

Safety Profile

The most common adverse reactions observed in children treated with esomeprazole magnesium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth, and sleepiness. The FDA explicitly notes that safety and efficacy have not been established in children under 1 year of age, and warns against use in this younger population.

Why This Matters for Practice

For pharmacists and paediatric care teams, this approval formalizes dosing guidance (10 mg or 20 mg daily for ages 1–11, versus 20 mg or 40 mg for ages 12–17) that clarifies a previously extrapolated off-label practice. Because the approval relies partly on adult efficacy data extrapolated to children, ongoing monitoring for adverse drug reactions — as the FDA itself emphasizes — remains an important counseling point for caregivers, alongside clear guidance on the two available formulations (capsule vs. liquid) to support adherence in younger patients who may have difficulty swallowing capsules.

Takeaway

This approval gives clinicians and pharmacists a clearly defined, age-specific dosing framework for esomeprazole magnesium in children as young as 1 year with GERD, backed by an 8-week paediatric safety and healing study. The most common adverse effects are generally mild and consistent with the known PPI safety profile in adults, but the FDA's caution around monitoring and its explicit exclusion of children under 1 year underscore that this remains a population requiring careful clinical oversight.

Reference

FDA Approves Nexium for Use in Children Ages 1–11 Years. Gastroenterology and Hepatology News. p. 1282.