Label Changes for:

Lipofen (fenofibrate) Capsules, 50 mg and 150 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

5.1 Coronary Heart Disease Morbidity and Mortality
  • results from the ACCORD Lipid trial
5.2 Skeletal Muscle
  • cases of myopathy, including rhabdomyolysis, have been reported in patients taking fenofibrates co-administered with colchicine
5.11 Paradoxical Decreases in HDL Cholesterol Levels
  • paradoxical decreases in HDL in patients taking fenofibrates

6 ADVERSE REACTIONS

6.2 Post-marketing Experience
  • paradoxical decreases in HDL in patients taking fenofibrates

7 DRUG INTERACTIONS

7.4 Colchicine
  • cases of myopathy, including rhabdomyolysis, have been reported in patients taking fenofibrates co-administered with colchicine

 

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