Label Changes for:
Avandia (rosiglitazone maleate) Tablets
Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.
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.|
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.