Label Changes for:

Triglide (fenofibrate) Tablets, 50 mg and 160 mg

January 2013

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)

 

January 2013

5 WARNINGS AND PRECAUTIONS

  • The Action to Control Cardiovascular Risk in Diabetes Lipid (ACCORD Lipid) trial was a randomized placebo-controlled study of 5518 patients with type 2 diabetes mellitus on background statin therapy treated with fenofibrate. The mean duration of follow-up was 4.7 years. Fenofibrate plus statin combination therapy showed a non-significant 8% relative risk reduction .....
5.11 Paradoxical Decreases in HDL Cholesterol Levels
  • There have been postmarketing and clinical trial reports of severe decreases in HDL cholesterol levels (as low as 2 mg/dL) occurring in diabetic and non-diabetic patients initiated on fibrate therapy. The decrease in HDL-C is mirrored by .....

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • added ..... severely depressed HDL cholesterol levels

7 DRUG INTERACTIONS

7.4 Colchicine
  • Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine
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