Label Changes for:

Glycet (miglitol) Tablets

April 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

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

 

Brand (Generic) Name

Sections Modified

Glycet (miglitol) Tablets

PRECAUTIONS

  • General
    • Macrovascular Outcomes –
      • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glycet or any other anti-diabetic drug.
    • Information for Patients
      • Physician Counseling Information for Patients: In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential...
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