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FDA Approves Esomeprazole for Use in Children Ages 1-11 Years

ROCKVILLE, Md -- February 28, 2008 -- The US Food and Drug Administration approved esomeprazole magnesium (Nexium) for short-term use in children ages 1 to 11 years for the treatment of gastro-oesophageal reflux disease (GORD/GERD). The agency approved esomeprazole in two forms, a delayed-release capsule and liquid form. Esomeprazole is approved in 10 mg or 20 mg daily for children 1 to 11 years old compared to 20 mg or 40 mg recommended for paediatric patients 12 to 17 years of age.

"This approval provides important information for appropriate dosing for children ages 1 to 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."

Esomeprazole, a proton pump inhibitor (PPI), decreases the amount of acid produced in the stomach and helps heal erosive oesophagitis.

FDA approved the use of esomeprazole in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the paediatric population, as well as safety and pharmacokinetic studies performed in paediatrics patients. In one study, 109 patients (aged 1-11 years) diagnosed with GERD were treated with esomeprazole once-a-day for up to 8 weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their oesophageal erosions after 8 weeks of treatment.

The most common adverse reactions in children treated with esomeprazole were headache, diarrhoea, abdominal pain, nausea, gas, constipation, dry mouth, and sleepiness. The safety and efficacy of esomeprazole has not been established in children younger than 1 year of age.


SOURCE: US Food and Drug Administration

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