Avandia (rosiglitazone maleate) Tablets

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

Summary View

Sections Modified

PATIENT PACKAGE INSERT

• What is Avandia?
  • ...Avandia has not been studied enough in children under 18 years of age to know if it is safe or effective in children.