FDA Approves Nexium for Use in Children Ages 1–11 Years

Abstract

The US Food and Drug Administration approved esomeprazole magnesium (Nexium) for short-term use in children ages 1–11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved esomeprazole magnesium in 2 forms, a delayed-release capsule and liquid form. Esomeprazole magnesium is approved in dosages of 10 or 20 mg daily for children 1–11 years old compared with 20 or 40 mg recommended for pediatric patients 12–17 years of age. “This approval provides important information for appropriate dosing for children ages 1–11 years with GERD,” said Julie Beitz, MD, director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. “Children prescribed this drug should be monitored by their physicians for any adverse drug reactions.” The proton pump inhibitor was approved in patients ages 1–11 years for short-term treatment of GERD based on the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In 1 study, 109 patients ages 1–11 diagnosed with GERD were treated with esomeprazole magnesium once-a-day for up to 8 weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after 8 weeks of treatment. The most common adverse reactions in children treated with esomeprazole magnesium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth, and sleepiness. The safety and efficacy of esomeprazole magnesium have not been established in children <1 year of age, the FDA warns.