Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
-

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.

 

-
-