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U.S. Department of Health and Human Services


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Resources for You

Actos (pioglitazone hydrochloride) Tablets December 2008

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


  • General
    • Macrovascular Outcomes (subsection added)
      • There have been no clinical studies establishing conclusive evidence of
        macrovascular risk reduction with Actos or any other antidiabetic drug.