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U.S. Department of Health and Human Services

Safety

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Antara (Fenofibric Acid) Capsules

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

Summary View

 

WARNINGS AND PRECAUTIONS

Mortality and Coronary Heart Disease Morbidity
  • The Action to Control Cardiovascular Risk in Diabetes Lipid (ACCORD Lipid) trial was a randomized placebo-controlled study of 5518 patients with type 2 diabetes mellitus on background statin therapy treated with Fenofibrate…
Skeletal Muscle
  • Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine
Paradoxical Decreases in HDL Cholesterol Level
  • 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.
 

ADVERSE REACTIONS

Postmarketing Experiences
  • …and severely depressed HDL-cholesterol levels…