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U.S. Department of Health and Human Services

Safety

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Janumet (sitagliptin/metformin HCl) Tablets February 2008


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Macrovascular Outcomes

PATIENT PACKAGE INSERT

  • What is Janumet?
  • Tell your doctor about all the medications you take...
  • What are the possible side effects of Janumet?

WARNINGS AND PRECAUTIONS

Macrovascular Outcomes

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