FDA Approves Nexium for Young Children

In February 2008, the FDA approved the proton-pump inhibitor (PPI) esomeprazole magnesium (Nexium) for short-term treatment of erosive esophagitis and gastroesophageal reflux disease (GERD) symptoms in children aged 1 to 11 years. Other PPIs — omeprazole and lansoprazole — have been available for treatment of erosive esophagitis and symptoms associated with GERD in children older than 1 year, and off-label use in infants is common. Esomeprazole is the S isomer of omeprazole. Its efficacy in children is extrapolated from adult studies, some of which demonstrate its superiority to omeprazole or lansoprazole for healing erosive esophagitis. In safety and pharmacokinetic studies of esomeprazole, conducted in children, the most common adverse reactions were diarrhea, headache, and sleepiness.

Esomeprazole is approved for short-term treatment, once daily, 1 hour before meals for 8 weeks. For children aged 1 to 11 years, 10 mg is recommended for those who weigh <20 kg, and 20 mg is recommended for those who weigh ≥20 kg. The recommended dose for children aged 12 to 17 years is 20 mg or 40 mg (the adult dose). Doses higher than 1 mg/kg daily have not been evaluated. Esomeprazole is available in liquid form and as a delayed-release capsule. The capsule can be opened and the intact granules can be mixed with applesauce or emptied into a syringe and delivered by nasogastric tube if necessary.