[Posted 11/09/2011]ISSUE:FDA notified healthcare professionals the cholesterol-lowering medicine fenofibric acid (Trilipix) 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 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 fenofibrate physician label and to the patient Medication Guide.
BACKGROUND:Fenofibric acid was approved by FDA in 2008 to treat cholesterol in the blood by lowering the total amount of triglycerides and low-density lipoprotein (LDL) cholesterol, and increasing the high-density lipoprotein (HDL) cholesterol.
RECOMMENDATION:Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in patients in two large randomized controlled trials of patients with type 2 diabetes mellitus; healthcare professionals should consider the benefits and risks of fenofibrate when deciding to prescribe the drug to patients, and counsel patients about those benefits and risks. For more information visit the FDA website at: Web Siteand Web Site.
Fenofibrate is used with a low-fat diet and sometimes with other medications to reduce the amounts of fatty substances such as cholesterol and triglycerides in the blood and to increase the amount of HDL (high-density lipoprotein; a type of fatty substance that decreases the risk of heart disease) in the blood. Build-up of cholesterol and fats along the walls of the arteries (a process known as atherosclerosis) decreases the blood flow and, therefore, the oxygen supply to the heart, brain, and other parts of the body. This increases the risk of heart disease, angina (chest pain), strokes, and heart attacks. Although fenofibrate decreases the levels of fatty substances in the blood, it has not been shown to decrease the risk of heart problems that may be caused by these substances. Fenofibrate is in a class of medications called antilipemic agents. It works by speeding the natural processes that remove cholesterol from the body.
Fenofibrate comes as a capsule, a delayed-release (long-acting) capsule, and a tablet to take by mouth. It is usually taken once a day. Some fenofibrate products (Fenoglide, Lipofen, and Lofibra) should be taken with a meal. Other brands (Antara, Fibricor, Tricor, Triglide, and Trilipix) may be taken with or without food. Ask your doctor or pharmacist if you do not know if you should take your medication with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fenofibrate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on an average dose of fenofibrate and may increase or decrease your dose depending on the results of laboratory tests that you will take to measure the amount of fatty substances in your blood. Your doctor may tell you to stop taking fenofibrate if your test results do not show improvement after 2 months.
If you are taking Trilipix tablets, swallow the tablets whole; do not split, chew, or crush them.
If you are taking Triglide tablets, do not use any tablets that are chipped or broken.
Fenofibrate will help decrease the amount of fatty substances in your blood only as long as you continue to take it. Continue to take fenofibrate even if you feel well. Do not stop taking fenofibrate without talking to your doctor.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Before taking fenofibrate,
- tell your doctor and pharmacist if you are allergic to any fenofibrate products, any other medications, or any of the ingredients in the fenofibrate product you are taking. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); diuretics ('water pills'); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); HMG-CoA reductase inhibitors (cholesterol-lowering agents) such as atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor); hormone replacement therapy; hormonal contraceptives (birth control pills, patches, implants, rings, and injections); and immunosuppressants such as cyclosporine (Sandimmune, Neoral) and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking a bile acid resin such as cholestyramine (Questran), colesevelam (WelChol), or colestipol (Colestid), take it 1 hour after or 4-6 hours before you take fenofibrate.
- tell your doctor if you have or have ever had kidney, liver, or gallbladder disease. Your doctor will probably tell you not to take fenofibrate.
- tell your doctor if you have or have ever had diabetes or hypothyroidism (underactive thyroid gland).
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking fenofibrate, call your doctor.
- tell your doctor if you are breast-feeding. You should not breast-feed while you are taking fenofibrate.
Follow a low-cholesterol, low-fat diet. Ask your doctor or nutritionist for more information.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Fenofibrate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- pain in the back, arm, or legs
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- muscle pain or tenderness
- joint pain
- blistering or peeling skin
- pain in the upper back between the shoulder blades or under the right shoulder
- stomach pain, especially in the upper right part of the stomach
- redness, swelling, pain, tenderness, or warmth in one leg
- shortness of breath
- pain when breathing
- coughing up blood
Fenofibrate may cause other side effects. Call your doctor if you have any unusual problems while you are taking fenofibrate.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain laboratory tests to check your response to fenofibrate.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
¶These branded products are no longer on the market and only generic alternatives are available.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: November 15, 2011.