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U.S. Department of Health and Human Services

Safety

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Fibricor (fenofibric acid) Tablets

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

 

December 2012

Summary View

 

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…
 

ADVERSE REACTIONS

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.

 

January 2012 

Summary View

ADVERSE REACTIONS 

Table 1

  • Liver Function Tests Abnormal...added

USE IN SPECIFIC POPULATIONS

8.5 Geriatric Use 
  • Elderly patients with normal renal function should require no dose modifications