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U.S. Department of Health and Human Services

Safety

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Nexium (esomeprazole magnesium) for Delayed Release Oral Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

 

Summary View

 

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • ...However, effectiveness has not been demonstrated in patients less than 1 year of age.
  • Neonates to less than one year of age
    • There was no statistically significant difference between Nexium and placebo in the rate of discontinuation in a multicenter, randomized, double-blind, controlled, treatment-withdrawal study of patients ages 1 to 11 months, inclusive. Patients were enrolled if they had either a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD.