Label Changes for:

Januvia (sitagliptin) Tablets

July 2008

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


 

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008 and April 2011

 

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.


 

April 2011

 

5 WARNINGS AND PRECAUTIONS

5.2 Renal Impairment
  • section added

 

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • ...worsening renal function..

 

MEDICATION GUIDE

  • ...worsening renal function...

 

July 2008

Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Macrovascular Outcomes

WARNINGS AND PRECAUTIONS

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Januvia or any other anti-diabetic drug.

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