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
