Label Changes for:
Janumet (sitagliptin/metformin hydrochloride) Tablets
April 2011
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011
5 WARNINGS AND PRECAUTIONS
5.4 Assessment of Renal Function
- section added
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- ...worsening renal function..
MEDICATION GUIDE
- ...worsening renal function...
