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Fenofibrate Side Effects, Interactions & Complications: How Well Does it Work?

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Q. You responded to a patient who was worried that his blood pressure may have gone up because of Trilipix (fenofibric acid) to lower cholesterol. Please be cautious when you tell someone a medication could be causing such a symptom.

The large majority of my patients on cholesterol-lowering drugs are just looking for a reason to stop their statin or fibrate. You reinforce their fears.

Most of my patients with high lipid levels also have hypertension, are overweight and insulin resistant. When you suggest that fenofibrate might elevate blood pressure, people all over the country will immediately stop their medicine without consulting their doctor.

Maybe some patients have elevated blood pressure from fenofibrate, but please tell people not to stop this medicine just because they have high blood pressure. They should consult their doctor first!

I am a physician in internal medicine in New Mexico.

A. Doctor, you are absolutely correct that no one should EVER stop ANY medicine without first consulting the prescribing physician!

That said, the drug in question (a fibrate-type cholesterol-lowering medication) is coming under increasing scrutiny at the FDA. A large study demonstrated that patients with diabetes taking statins plus a fibrate did not reduce their risk of developing a heart attack or stroke. In fact, there was a trend towards more heart attacks in women taking the fibrate plus statin than in women just taking a statin alone.

The article in the New England Journal of Medicine (April 29, 2010) produced an unexpected outcome in that the fibrate did not produce desirable cardiovascular results. The FDA went on to issue a safety announcement:

"The U.S. Food and Drug Administration (FDA) is informing the public that the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke."

Another unanticipated problem of fenofibrate is the lowering of good HDL cholesterol levels. The FDA issued a safety alert about Tricor (fenofibrate) because of "reports of severe decreases in HDL cholesterol levels...This decrease has been reported to occur within 2 weeks to years after initiation of fibrate therapy." The FDA calls for periodic monitoring of HDL levels in patients on fibrates. If the levels go down, the fibrate therapy "should be withdrawn."

FENOFIBRATE SIDE EFFECTS & INTERACTIONS

  • Liver enzyme elevations, liver damage, hepatitis, cirrhosis, gall bladder problems
  • Digestive distress, stomach pain, nausea, constipation
  • Breathing problems, runny nose, bronchitis
  • Headache
  • Muscle breakdown, CK enzyme elevation, muscle pain
  • Fatigue
  • Pancreatitis
  • Allergic skin reactions (requires immediate medical attention)
  • Blood disorders
  • Reduction in HDL cholesterol levels
  • Hypertension (associated with fenofibric acid)

 

Please check with your pharmacist before adding fenofibrate to any other medication. Blood pressure medications containing diuretics may work at cross purposes to the cholesterol-lowering medicine. The drug colchicine may be harder on muscles and cause dangerous muscle breakdown [rhabdomyolysis] when combined with fenofibrate. Estrogen may increase the risk of gallbladder disease if added to fibrate therapy.

Share your own story about fenofibrate below. Here are some comments from other visitors to this website:

"My internist retired and I was 'given' to a new, young internist. Without any blood tests or even listening to my heart he had me start on  Trilipix (fenofibric acid). It was a lot more expensive than what I had been taking for cholesterol.

"After a month or so I broke out in a rash on my torso and went to my dermatologist. He looked at my list of medications and said to stop the Trilipix immediately.

"A rash is minor compared to what some patients endured but I now make it a practice to look up any new medication I receive, especially if the doctor tells me to take it from now on." Penny


"I was taking TriCor which is listed as not being a statin but my knees had began hurting so bad and were very tender to the touch... actually the entire skin area around my knees was tender too... Within a month of stopping the drug, I have no  more knee pain and my skin is not tender to the touch!" T.B.


"I have always had trouble with cholesterol  meds. Just recently my doctor prescribed TriCor. After taking it a month I had constipation and bloating and pain in my stomach. I believe the drug was the problem because I have never had problems with my bowels before the TriCor." M.J.


Learn about other strategies for controlling cholesterol in our Guide to Cholesterol Control & Heart Health. Report your own fenofibrate experience below.

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P Pharm,
Fenofibrate comes in two forms. One is micronized and the other has no special designation. I have asked pharmacists and doctors what the difference is and have not had any meaningful answers as to why use one or the other. Micronized is much more expensive. This is my wife's medication. Will you please describe the differences pro and con and why or why not use one or the other?

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Share your comments or questions with the People's Pharmacy online community. Not all comments will be posted. Advice from other visitors to this web site should not be considered a substitute for appropriate medical attention. Concerns about medications should be discussed with a health professional. Do not stop any medication without first checking with your physician.

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