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
| Sections Modified | Summary of Changes to Contraindications and Warnings |
|
WARNINGS AND PRECAUTIONS
|
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. |
