Nexium Approved for Kids
FDA Approves Nexium for Use in Children Ages 1-11 Years
The U.S. Food and Drug Administration approved Nexium (esomeprazole
magnesium) for short-term use in children ages 1-11 years for the treatment of
gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms,
a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams
(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.
"This approval provides important information for appropriate dosing for
children ages 1-11 years with GERD," said Julie Beitz, M.D., 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."
Nexium is part of a class of drugs known as proton pump inhibitors (PPIs).
PPIs decrease the amount of acid produced in the stomach and help heal erosions
in the lining of the esophagus known as erosive esophagitis.
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.
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, DE.
SOURCE: FDA News Release, February 28, 2008
Last Editorial Review: 2/28/2008
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