Proton Pump Inhibitor Use in Infants and Children

A Review of the Recent Literature

Marcia L. Buck, PharmD, FCCP, FPPAG, BCPPS


Pediatr Pharm. 2019;25(7) 

In This Article

Abstract and Introduction


Proton pump inhibitors (PPIs), including omeprazole esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, and rabeprazole, are effective agents for suppressing gastric acid production, making them a useful tool in the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, or gastric bleeding in children and adults.[1] These drugs account for 95% of prescriptions for gastric acid suppressive agents written in the United States, with more than 150 million prescriptions written for a PPI in 2014. Over-the-counter purchases of PPIs account for more than 10 billion dollars in annual sales world-wide.

Premarketing clinical trials of PPIs documented a mild adverse effect profile; however, the duration of these studies was often 12 weeks or less. After approval by the Food and Drug Administration (FDA), widespread use, often for extended periods, revealed more serious adverse effects. Based on the accumulation of these reports, the FDA issued a safety alert on PPI-associated hypomagnesemia on March 2, 2011, another on the association between extended use of PPIs and fractures on March 23, 2011, and a third describing an increased risk for Clostridium difficile infections in patients taking PPIs on February 8, 2012.[2–4] Subsequent studies and meta-analyses have documented an association between PPIs and other enteric infections, hospital or community-acquired pneumonia (CAP), urinary tract infections, decreased absorption of calcium and vitamin B12, allergic disease, gynecomastia, obesity, and chronic kidney disease.[1,5] Causal relationships between PPIs and these additional adverse effects have not been fully established.