Label Changes for:

Antara (fenofibrate) Capsules

June 2008

Changes have been made to the WARNINGS sections of the safety label.


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

  • Other Considerations

PRECAUTIONS

  • Venothromboembolic Disease

WARNINGS: Other Considerations

The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was a 5- year randomized, placebo-controlled study of 9795 patients with type 2 diabetes mellitus treated with fenofibrate. Fenofibrate demonstrated a non-significant 11 % relative reduction in the primary outcome of coronary heart disease events (hazard ratio (HR) 0.89, 95% CI 0.75-1.05, p=0.16) and a significant 11% reduction in the secondary outcome of total cardiovascular disease events (HR 0.89 (0.89-0.99), p=0.04). There was a non-significant 11 % (HR 1.11 (0.95, 1.29), p=0.18) and 19% (HR 1.19 (0.90, 1.57), p=0.22) increase in total and coronary heart disease mortality, respectively, with fenofibrate as compared to placebo.

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