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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adverse reactions reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials are listed in Table 1. Adverse reactions led to discontinuation of treatment in 5% of patients treated with fenofibrate and in 3% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Reactions Reported by 2% or More of
Patients Treated with Fenofibrate* During the Double-Blind, Placebo-Controlled
BODY AS A WHOLE
|Abnormal Liver Function Tests||7.5%**||1.40%|
METABOLIC AND NUTRITIONAL DISORDERS
|* Fenofibric acid is the active moiety of fenofibrate;
Fenofibrate dosage equivalent to 105 mg fenofibric acid.
** Significantly different from Placebo.
The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, muscle spasm, acute renal failure, hepatitis, cirrhosis, anemia, headache, arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases, asthenia, and severely depressed HDL-cholesterol levels. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the Fibricor (fenofibric acid) Side Effects Center for a complete guide to possible side effects
Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR.
Caution should be exercised when coumarin anticoagulants are given in conjunction with FIBRICOR. The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized [see WARNINGS AND PRECAUTIONS].
Bile-Acid Binding Resins
Since bile-acid binding resins may bind other drugs given concurrently, patients should take FIBRICOR at least 1 hour before or 4 to 6 hours after taking a bile-acid binding resin to avoid impending its absorption.
Immunosuppressant agents such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs, including FIBRICOR, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using FIBRICOR with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed and renal function monitored.
Read the Fibricor Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/21/2014
Additional Fibricor Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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