National Study of Off-label Proton Pump Inhibitor Use Among New Zealand Infants in the First Year of Life (2005-2012).

OBJECTIVES: Off-label prescribing of proton pump inhibitors (PPIs) to infants to treat symptoms attributed to gastroesophageal reflux disease (GERD) is widely reported, despite evidence that PPIs are no more effective than placebo in relieving those symptoms. To initiate discussion about appropriate prescribing of these drugs for infants, we describe the characteristics of PPI use among infants in New Zealand.

METHODS: In this population-based study we used routinely collected dispensing data to identify all children born between 2005 and 2012 who were dispensed a government-subsidized PPI (omeprazole, lansoprazole, pantoprazole) before their first birthday. Unique patient identifiers were used to link administrative datasets containing patient-level demographic, dispensing, and health information.

RESULTS: In total, 22,643 children were dispensed a study PPI before their first birthday. The prevalence of infant PPI use as a proportion of all live births increased from 2.4% for children born in 2005 to 5.2% for children born in 2012. Overall, 71.6% of infants were dispensed a PPI by 3 months of age, and 8.7% received a PPI within the first month of life. Before PPI initiation, only 7.0% of infants had a hospital-based diagnosis of GERD (with or without esophagitis), and 4.7% of infants had a hospital-based diagnosis of one or more known or suspected GERD risk factors.

CONCLUSIONS: Off-label prescribing of PPIs to New Zealand infants was relatively common and increased over the study period. The appropriateness of PPI treatment should be questioned, as the majority of infants who received these drugs were not diagnosed with severe GERD.