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Diabeta (glyburide) Tablets March 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009


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


Sections Modified

Summary of Changes to Contraindications and Warnings



  • Hemolytic anemia
  • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction
  • Drug Interactions
    • Clarithromycin (hypoglycemic action of sulfonylureas may be potentiated)
    • bosentan and cyclosporine


  • hypersensitivity to any of the drug’s excipients and patients treated with bosentan