Label Changes for:

Trilipix (fenofibric acid) Delayed Release Capsules

September 2012

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) – September 2012

 

5 WARNINGS AND PRECAUTIONS

5.2 Skeletal Muscle
  • Cases of myopathy, including rhabdomyolysis.....
5.11 Paradoxical Decreases in HDL Cholesterol Levels
  • paradoxical decreases in HDL-C in patients taking fenofibrates
  • cases of myopathy, including rhabdomyolysis, have been reported in patients taking fenofibrates co-administered with colchicine

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • paradoxical decreases in HDL-C in patients taking fenofibrates
  • cases of myopathy, including rhabdomyolysis, have been reported in patients taking fenofibrates co-administered with colchicine
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