Following a review of study data, Abbott’s TRILIPIX (fenofibric acid) may only lower the risk of heart attack and stroke in a small group of high-risk patients, and following a request from the Food and Drug Administration, has updated the drug’s label, accordingly to reflect this new information. In addition, the FDA is requiring Abbott to conduct a study testing the cardiovascular effects of TRILIPIX in patients taking statins and at high risk for heart disease.
The FDA is now requiring the product label for fenofibric acid to contain the following statement in the “Important Limitations of Use” section: “No incremental benefit of TRILIPIX on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg. of TRILIPIX was not shown to reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus.”
The FDA has approved fenofibric acid to treat cholesterol by lowering LDL cholesterol (“bad cholesterol”) and increasing HDL (“good cholesterol”). It is also approved to lower very high levels of trigylcerides (fat) in the blood to help reduce the risk of pancreatitis. It can also be used in combination with statins, such as Zocor, in patients at high risk for cardiovascular disease.
The randomized, double-blind, placebo-controlled clinical trial which was ordered by the FDA will test whether TRILIPIX in combination with a statin vs. statin alone significantly reduces cardiovascular incidents in high-risk men and women who are at their LDL cholesterol goal on statin therapy, but have residually high triglycerides and low HDL cholesterol. Abbott confirmed that it plans on conducting a new trial.
In addition to requiring the recent label change, the FDA also requires fenofibric acid be dispensed with an FDA-approved Medication Guide written specifically for consumers in nontechnical language. The FDA has the authority to require Medication Guides for drugs that present serious public health concerns, including fenofibric acid.
One of the main safety messages in the fenofibric acid Medication Guide is that using fenofibric acid in combination with a static drug can increase the risk of adverse drug reaction called rhabdomyolysis, which can lead to kidney damage and death. Symptoms include muscle pain, tenderness or weakness.
Although this medication may not lower heart attack or stroke risk for certain, you should discuss with your doctor if the benefits of this drug would be of help to you. Until the results of the new study are published, it is a gamble to say the least.
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