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FDA Medwatch Alert: Trilipix (fenofibric acid): Drug Safety Communication - Label Change
Posted 9 Nov 2011 by Drugs.com
ISSUE: FDA notified healthcare professionals the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke. FDA reviewed the data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. 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 the trial has been added to the Important Limitations of Use and Warnings and Precautions sections of the Trilipix physician label and to the patient Medication Guide. BACKGROUND: Trilipix (fenofibric acid) was approved by FDA in 2008 to treat cholesterol in the blood by lowering the total amount of triglycerides and low-density lipoprotein (LDL) cholesterol, and increasing the high-density ... Read more
Posted 22 Mar 2011 by Drugs.com
TUESDAY, March 22 – Use of a class of cholesterol-lowering drugs called fibrates is on the rise in the United States despite research that suggests they may not do much to improve health, researchers say. Fibrates are often prescribed to people with low levels of HDL ("good") cholesterol and high levels of triglycerides, a harmful form of fat circulating in the blood, experts explained. The new study isn't questioning the ability of fibrates to lower triglycerides, said lead study author Cynthia A. Jackevicius, an associate professor of pharmacy at Western University of Health Sciences in Pomona, Calif. Fibrates have also been shown to have a "modest" effect on raising HDL cholesterol. (Statins, another hugely popular family of cholesterol drugs that includes brands such as Lipitor and Zocor, are used to lower LDL, or "bad, cholesterol.) The real question, according to the study ... Read more
Related support groups: High Cholesterol, Fenofibrate, Tricor, Gemfibrozil, Trilipix, Lopid, Antara, Fenofibric Acid, Lipofen, Dom-Fenofibrate, Triglide, Lipidil EZ, Lofibra, Fenoglide, Lipidil Micro, Fibricor, Clofibrate, Lipidil Supra, Atromid-S