FDA approves use of Nexium in children ages 12 to 17 for short-term treatment of GERD

By Lisa Kerner

Erie, Pa., May 1 - AstraZeneca said the Food and Drug Administration has approved the use of Nexium (esomeprazole magnesium) delayed-release capsules in children ages 12 to 17 for the short-term treatment of gastroesophageal reflux disease (GERD).

Nexium's safety was evaluated in a multicenter, randomized, double-blind parallel group study of 149 patients ages 12 to 17 with clinically diagnosed GERD. Patients were treated with either Nexium 20 mg or Nexium 40 mg once daily for up to eight weeks

AstraZeneca said the most frequently reported treatment-related adverse events were headache, abdominal pain, diarrhea and nausea.

GERD, a condition in which the contents of the stomach back up into the esophagus, affects about 8% of U.S. children between the ages of 12 and 17.

AstraZeneca, located in Wilmington, Del., researches, develops, manufactures and markets prescription pharmaceuticals and health care supply services.

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