Fenofibric Acid Label Update

Drug Alerts , News / September 27, 2016

The FDA notified healthcare professionals that cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient’s risk of having a heart attack or stroke. This was based on data reviewed from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. Fenofibric acid is the active form of fenofibrate.

The ACCORD Lipid trial found no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone. Information from this trial has been added to the Important Limitaitons of Use and Warnings and Precuations sections of the Tripilix physician label and to the patient Medication Guide.

Trilipix was approved by the FDA in 2008 to treat cholesterol in the blood by lowering the total amount of triglycerides and low-density lipoproteins (LDL) cholesterol, and increasing the high density lipoprotein (HDL) cholesterol.

Fenofibrate in a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in patients in two large randomized controlled trials of patients with type II diabetes mellitus. Healthcare professionals should consider the benefits and risk of Trilipix when prescribing the drug to patients, and advice patients accordingly.

No Comments

Leave a Reply

%d bloggers like this:
Skip to toolbar