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Proton pump inhibitor use in infants: FDA reviewer experience

Ii-Lun Chen1, Wen-Yi Gao, Aisha P Johnson

  • 1Division of Gastroenterology and Inborn Errors Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993-0002, USA.

Journal of Pediatric Gastroenterology and Nutrition
|September 28, 2011
PubMed

Insights

Proton pump inhibitors (PPIs) did not show benefits for treating gastroesophageal reflux disease (GERD) in infants. Healthy infants without acid-induced disease should not receive PPIs for GERD symptoms.

Area of Science:

  • Pediatric Gastroenterology
  • Pharmacology
  • Clinical Trial Analysis

Background:

  • Gastroesophageal reflux disease (GERD) is common in infants.
  • Proton pump inhibitors (PPIs) are frequently prescribed for infant GERD.
  • Previous clinical trials have yielded inconclusive results regarding PPI efficacy in infants.

Purpose of the Study:

  • To review clinical trial data on PPI use in infants (1 month to <12 months) for GERD.
  • To discuss reasons for the lack of demonstrated benefit in prior studies.
  • To evaluate the safety of long-term PPI use in this population.

Main Methods:

  • Systematic review of 4 clinical trials evaluating PPIs in infants with GERD.
  • Analysis of trial findings and discussion of potential mechanistic explanations.
  • Consideration of safety data from long-term PPI exposure.

Main Results:

  • Clinical trials failed to demonstrate a significant benefit of PPIs in treating GERD symptoms in infants.
  • Potential reasons for treatment failure were explored, including developmental differences in infants.
  • Safety concerns regarding long-term PPI use in infants were noted.

Conclusions:

  • PPIs should not be routinely administered to healthy infants for GERD symptoms.
  • Treatment should be reserved for infants with confirmed acid-induced disease.
  • Further research is needed to understand PPI efficacy and safety in pediatric populations.

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