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U.S. Department of Health and Human Services

Safety

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Glynase PresTab (micronized glyburide tablets) October 2008

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

PRECAUTIONS

  • Macrovascular Outcomes
    • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glynase PresTab or any other anti-diabetic drug.
  • Physician Counseling Information for Patients (new)