Feb. 28, 2008 — The FDA today approved short-term use of the drug Nexium for children aged 1-11 with gastroesophagealreflux disease (GERD).
The FDA OK’d Nexium in two forms — a delayed-release capsule and a liquidform — 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 mgdoses.
“This approval provides important information for appropriate dosing forchildren ages 1-11 years with GERD,” Julie Beitz, MD, director of the FDA’sOffice for Drug Evaluation III in the Center for Drug Evaluation and Research.”Children prescribed this drug should be monitored by their physicians forany 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 erosionsin the lining of the esophagus, a condition known as erosiveesophagitis.
The FDA approved Nexium’s use in children aged 1-11 for short-term treatmentof GERD based data extrapolated from previous studies done in adults, as wellas studies done in children.
In one study, 109 GERD patients aged 1-11 were treated with Nexium oncedaily for up to eight weeks to evaluate Nexium’s safety and tolerability. Mostof the patients showed healing of their esophageal erosions after eight weeksof treatment.
Nexium isn’t approved for children younger than 1. The drug’s safety andefficacy hasn’t been established in children in that age range, the FDAnotes.
Nexium is made by the drug company AstraZeneca.