The FDA said today that the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke. The label for the drug has been changed and healthcare professionals are being notified.
This new information came from a study which showed no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with the drug and the group not treated with the drug. An analysis of a smaller group in the study showed that in relation to men, there was an increase in the risk for major adverse cardiac events in women receiving the drug versus those who didn't.
The FDA is requiring the manufacturer of Trilipix to conduct a trial to evaluate cardiovascular events in Trilipix patients.
Bottom line: A cholesterol drug, on the market, being prescribed and sold to patients, which has not been shown to lower a patient's risk of having a heart attack or a stroke, and which may in fact cause women to have an increased risk for adverse cardiac events.
This is healthcare at its finest. But no need to fear; the drug is on the market, the drug company that makes it (Abbott) is making lots of money from it, and a clinical trial is in the works which, years from now, will tell us if, in fact, people not only wasted their money on Trilipix, but their health was actually made worse by taking it.