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U.S. Department of Health and Human Services

Safety

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Cimzia (certolizumab pegol) January 2009

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

 

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

BOXED WARNING [updated]

WARNINGS AND PRECAUTIONS

MEDICATION GUIDE

BOXED WARNING [updated]

  • Risk of Serious Infections.

WARNINGS AND PRECAUTIONS

MEDICATION GUIDE

  • risk of histoplasmosis with the use of the class ofTNF-inhibitors.