Nexium Approved for Children 1 to 11 Years Old
On Feb. 28, 2008, FDA announced its approval of the short-term use of Nexium in children 1 to 11 years old for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms: delayed-release capsule and liquid.
"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," says Julie Beitz, M.D., Director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."
What is Nexium?
Nexium (esomeprazole magnesium) is part of a class of drugs known as proton pump inhibitors (PPIs). These drugs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus (erosive esophagitis). Nexium is manufactured by AstraZeneca of Wilmington, Del.
What dosages are included in this approval?
Nexium is approved for short-term use in 10 milligrams (mg) or 20 mg daily for children ages 1 to 11 years old (compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years old).
What did FDA base this approval on?
FDA based this approval 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. Pharmacokinetic studies show how our bodies absorb, distribute, metabolize, and excrete drugs.
In one study, 109 patients, ages 1 to 11 years old who had been diagnosed with GERD, were treated with Nexium once a day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.
What are the most common adverse reactions in children treated with Nexium?
The most common adverse reactions were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth, and sleepiness.
What about using Nexium in children younger than 1 year?
The safety and effectiveness of Nexium has not been established in children less than one year old.
This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.
Date Posted: March 3, 2008