Proton Pump Inhibitor Use in Infants

Abstract

The Food and Drug Administration has completed its review of 4 clinical trials evaluating the use of proton pump inhibitors (PPIs) in infants (ages 1 month to <12 months) for the treatment of gastroesophageal reflux disease (GERD). An Advisory Committee meeting was held in November 2010 to discuss the potential reasons why PPI use in these trials failed to show a benefit in infants with GERD, and directions for future study. The present review summarizes the findings from the clinical trials. Potential mechanisms for the failed clinical trials are discussed. The safety of long-term use is also discussed. As a result of our analysis and review, the authors agree with the Advisory Committee members that PPIs should not be administered to treat the symptoms of GERD in the otherwise healthy infant without the evidence of acid-induced disease.

Esophageal impedance baselines in infants before and after placebo and proton pump inhibitor therapy

“…PPI therapy is proven effective for healing esophagitis in adults (13)(14)(15), for reducing acid exposure in infants (16)(17)(18) and is suggested to heal erosive esophagitis in 89% of children (19). However PPIs have not been proven to relieve symptoms of GERD in infants (20)(21)(22). The diagnosis and treatment of infantile GERD remains controversial with no evidence supporting empirical PPI therapy for treating GER clinical signs, such as irritability, vomiting and feed refusal (21,23).…”

Gastroesophageal Reflux

“…Therefore, acid-reducing medication is often prescribed in infants [49,55]. Several randomized controlled trials were performed in this indication, and for once all results indicate the same conclusion: PPIs are useless to decrease crying and distressed behavior in newborns and infants [56][57][58][59]. Heine and coworkers showed the absence of any relation between crying duration and result of pH monitoring [15].…”

“…Between 2002 and 2009, there was an 11-fold increase of the use of PPI in the USA [57]. In 2010, lansoprazole was the 9th and ranitidine the 14th most prescribed drug in children under 2 years of age in the USA [55].…”

Using Probiotics Instead of Pharmaceuticals to Treat Gastrointestinal Disorders

“…PPIs have been shown to be more damaging to the microbiome than antibiotics [8,26]. H2 blockers and PPIs are now being prescribed to infants and children [27]. This may result in modifying an individual's microbiome from an early age, leading to a lifetime of complications arising from microbiome dysbiosis.…”