Failure of Proton Pump Inhibitors to Treat GERD in Neonates and Infants: A Question of Drug, Diagnosis, or Design

“The only time you don't fail is the last time you try anything—and it works.” –William Strong Distressful symptoms associated with gastroesophageal reflux constitute a clinical description of gastroesophageal reflux disease, a pathologic condition commonly treated with proton pump inhibitors (PPIs). Despite their pervasive use in neonates and infants, PPIs have not been approved for gastroesophageal reflux disease treatment in this population. This creates a therapeutic conundrum: namely, whether to institute PPI treatment based on knowledge and experience or to withhold it consequent to absence of labeling for young infants. Clinical Pharmacology & Therapeutics (2012); 92 3, 388–392. doi:10.1038/clpt.2012.86