Label Changes for:
Fibricor (Fenofibric Acid) Tablets
December 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)
December 2012
WARNINGS AND PRECAUTIONS
Skeletal Muscle
- Fibrates increase the risk for myopathy and have been associated with rhabdomyolysis…
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…
