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U.S. Department of Health and Human Services

Safety

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Trilipix (fenofibric acid) Delayed Release Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2012

 

Summary View

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