FDA approves Nexium for short-term pediatric use

ROCKVILLE, Md. The Food and Drug Administration on Thursday approved prescription Nexium for short-term use in children ages 1-to-11 years for the treatment of gastroesophageal reflux disease in two forms, a delayed-release capsule and liquid form.

“This approval provides important information for appropriate dosing for children ages 1-11 years with GERD,” stated Julie Beitz, 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.”

FDA approved the use of Nexium 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 pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, 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.

Nexium is approved in 10 mg or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.

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

Nexium is manufactured by AstraZeneca of Wilmington, Del.