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U.S. Department of Health and Human Services

Safety

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Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) March 2009

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

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Reduction in Bone Mineral Density

WARNINGS and PRECAUTIONS

  • Reduction in Bone Mineral Density
    • 2-Year Fluticasone Propionate Study
    • 3-Year Bone Mineral Density Study
    • 3-Year Survival Study

 

The latest label (3/31/2009) is not available on this site