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Feb. 28, 2008 -- The FDA today approved short-term use of the drug Nexium for children aged 1-11 with gastroesophageal reflux disease (GERD).
The FDA OK'd Nexium in two forms -- a delayed-release capsule and a liquid form -- in doses of 10 milligrams or 20 milligrams for kids aged 1-11.
Nexium was already approved for children aged 12-17 in 20 mg or 40 mg doses.
"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," Julie Beitz, MD, director of the FDA's Office for 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, a condition?known as erosive esophagitis.
The FDA approved Nexium's use in children aged 1-11 for short-term treatment of GERD based data extrapolated from previous studies done in adults, as well as studies done in children.
In one study, 109 GERD patients aged 1-11 were treated with Nexium once daily for up to eight weeks to evaluate Nexium's safety and tolerability. Most of the patients showed 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.
Nexium isn't approved for children younger than 1. The drug's safety and efficacy hasn't been established in children in that age range, the FDA notes.
Nexium is made by the drug company AstraZeneca.