Glucophage (metformin hydrochloride tablets) August 2008

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

• General
  • Macrovascular Outcomes
    • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glucophage or Glucophage XR or any other anti-diabetic drug.