• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
?
-

Resources for You

Celebrex (celecoxib) Capsules December 2008

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

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Cardiovascular Thrombotic Events

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

  • Nursing Mothers
  • Poor Metabolizers of CYP2C9 Substrates

WARNINGS AND PRECAUTIONS

  •  Cardiovascular Thrombotic Events
    • In the APC (Adenoma Prevention with Celecoxib) trial, the hazard ratio.....