Label Changes for:
ActoPlus Met (pioglitazone HCl plus metformin HCl tablets), 15 mg/500mg and 15 mg/850 mg
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) -- January 2009
|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.|
- Macrovascular Outcomes
- ...no clinical studies establishing conclusive evidence ...