Objectives: In 2011, the Food and Drug Administration (FDA) approved intravenous esomeprazole 0.5 mg/day for children aged >1 month and oral esomeprazole for infants aged 1 month to <1 year at doses of 2.5, 5, and 10 mg based on weight. Prior to 2011, proton pump inhibitors (PPIs) were not approved for use in infants aged <1 year. This study determined PPI usage rates prior to the FDA approval among newborns and infants in both the inpatient and outpatient settings and compared PPI and histamine-2 receptor antagonist (H2RA) usage in the inpatient setting.
Methods: We conducted a retrospective analysis of PPI prescribing patterns for newborns and infants from 2003 to 2008 using data from the Premier Perspective Inpatient Hospital Database and the PharMetrics Patient-Centric Database for inpatient and outpatient data, respectively. PPI use and diagnoses were determined from clinical and charge records from more than 500 hospitals. Descriptive statistics were used to summarize the findings.
Results: Our analysis showed that PPIs were prescribed for approximately 5000 newborns (0.13%) and 15,000 infants (2.65%) each year in the hospital setting and 1.6% of newborns and infants, as a group, in the outpatient setting. Newborns and infants receiving PPIs most often had diagnoses of gastroesophageal reflux disease (GERD) and were generally prescribed an adult PPI dose, although the actual dose administered could not be substantiated.
Conclusions: Although no PPI was approved by the FDA for patients aged <1 year at the time of this study, results of this analysis indicate that PPIs were commonly prescribed for newborns and infants, mostly in hospital, but also in outpatient settings. Most PPIs were prescribed for infants with a diagnosis of GERD.
Keywords: GERD; esomeprazole; gastroesophageal reflux disease; pediatric use.