November 09, 2011
SAFETY ALERT: Trilipix May Not Lower Heart Attack or Stroke RiskThe FDA has notified healthcare professionals that the cholesterol-lowering medicine Trilipix (fenofibric acid; Abbott) 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 + 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.
Trilipix is a fenofibric acid indicated as an adjunct therapy to help lower triglycerides and LDL cholesterol and to raise HDL cholesterol in patients with hyperlipidemia.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm279185.htm.