Label Changes for:
Fortamet (metformin hydrochloride) Extended-Release Tablets
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) -- July 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.|
- Microvascular Outcomes
- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Fortamet or any other anti-diabetic drug.