FDA Revises Warning Label for Trilipix

On Wednesday, the Food and Drug Administration (FDA) notified healthcare professionals that the cholesterol-lowering medicine Trilipex (fenofibric acid) may not lower a patient’s risk of having a heart attack or stroke. The action came after the FDA reviewed the data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. That 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 Trilipex physician label and to the patient Medication Guide.

Click here to read the FDA Medwatch safety alert, including a link to the Drug Safety Communication.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Click here to complete and submit the report Online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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