Label Changes for:

Prevacid (lansoprazole) For Delayed-Release Oral Suspension

October 2008

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

USE IN SPECIFIC POPULATIONS

  • Pregnancy
    • Teratogenic effects
  • Pediatric Use
    • Initial Paragraph
      • ...Prevacid was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter...
        double-blind, placebo controlled study.
    • Neonate to less than 1 year of age (new)

NONCLINICAL TOXICOLOGY

  • Carcinogenesis, Mutagenesis, Impairment of Fertility
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