Nexium (esomeprazole magnesium,
AstraZeneca).
by McNamara, Damian
The Food and Drug Administration approved the proton pump inhibitor
esomeprazole magnesium (Nexium, AstraZeneca) for short-term treatment of
gastroesophageal reflux disease (GERD) in patients aged 1-11 years.
* Recommended Dosage: The recommended dosage is 10 mg or 20 mg
daily for children aged 1-11 years, and 20 mg or 40 mg for patients aged
12-17 years. Physicians can choose between a delayed-release capsule and
a new 10-mg delayed-release oral suspension.
* Special Considerations: Headache, diarrhea, abdominal pain,
nausea, gas, constipation, dry mouth, and sleepiness were reported in
clinical trials of children taking esomeprazole magnesium.
* Comment: "This approval provides important information for
appropriate dosing for children ages 1-11 years with GERD," Dr.
Julie Beitz, director of the FDA's Office of Drug Evaluation III in
the Center for Drug Evaluation and Research, stated in a news release.
The agent was previously approved for adolescents aged 12-17 years.
"The approval is very relevant.... This approval provides an
example of the pediatric rule effectively working," Dr. Benjamin D.
Gold said in an interview. "'This is also only the second PPI
with an indication down to age 1 year, lansoprazole [Prevacid] being the
other."
Efficacy for pediatric patients is extrapolated from adult studies.
Safety and tolerability are based on a multicenter, randomized,
double-blind, and open-label study of children aged 1-11 years with
endoscopy-confirmed GERD.
Most esophageal erosions healed among the 109 patients treated for
8 weeks. The once-daily study regimen included either 5 mg or 10 mg
esomeprazole for children weighing less than 20 kg, or 10 mg or 20 mg
esomeprazole for children weighing 20 kg or more.
"I have used the medication and found it to be effective,
safe, and easy to administer, as have my colleagues," said Dr.
Gold, professor of pediatrics and microbiology, and the Marcus Professor
and director of pediatric gastroenterology, hepatology, and nutrition,
Emory University, Atlanta.
Dr. Gold is a consultant to Astra-Zeneca Pharmaceuticals LP; a
consultant for Wyeth Research; an advisory board member for Santarus
Inc.; and a consultant to, speakers" bureau member for, and grant
recipient from TAP Pharmaceutical Products Inc. for an
investigator-initiated study.
BY DAMIAN McNAMARA, MIAMI BUREAU
COPYRIGHT 2008 International Medical News
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