Label Changes for:

Avandia (rosiglitazone maleate) Tablets

October 2008

Changes have been made to the WARNINGS and 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

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Myocardial Ischemia

MEDICATION GUIDE

  • What is the most important information I should know about Avandia?
  • What are the ingredients in Avandia?

WARNINGS AND PRECAUTIONS

Myocardial Ischemia:

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Avandia or any other oral antidiabetic drug.

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