Before Using This Medicine

In addition to its helpful effects in treating your medical problem, this type of medicine may have some harmful effects.

Results of large studies using other agents that are similar to fenofibrate seem to suggest that fenofibrate may increase the patient's risk of cancer, pancreatitis (inflammation of the pancreas), gallstones, and problems from gallbladder surgery.

Studies with fenofibrate in rats found an increased risk of liver and pancreatic tumors when doses up to 6 times the human dose were given for a long time.

Be sure you have discussed this with your doctor before taking this medicine.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fenofibrate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fenofibrate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Pregnancy—Fenofibrate has not been studied in pregnant women. However, studies in animals have shown that high doses of fenofibrate may increase the number of fetal deaths, decrease birth weight, or cause some skeletal defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether fenofibrate passes into breast milk. Studies in animals have shown that high doses of fenofibrate may increase the risk of some kinds of tumors. Therefore, this medicine is not recommended for use during breast-feeding.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of fenofibrate in children with use in other age groups.

Older adults—Although the effects of fenofibrate have not been fully tested in older people, this medicine has been tested in a limited number of patients 77 through 87 years of age and has not been shown to cause problems when given to older people.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fenofibrate, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners)—Use with fenofibrate may increase the effect of the anticoagulant and increase the risk of bleeding

• Carmustine (e.g., BiCNU) or
• Cisplatin (e.g., Platinol) or
• Combination pain medicine containing acetaminophen and aspirin (e.g., Excedrin) or other salicylates or
• Cyclosporine (e.g., Sandimmune) or
• Deferoxamine (e.g., Desferal) (with long-term use) or
• Gold salts (medicine for arthritis) or
• Inflammation or pain medicine, except narcotics, or
• Lithium (e.g., Lithane) or
• Methotrexate (Mexate) or
• Other medicine for infection or
• Penicillamine (e.g., Cuprimine) or
• Plicamycin (e.g., Mithracin) or
• Streptozocin (e.g., Zanosar) or
• Tiopronin (Thiola)—Concurrent use of these medicines with fenofibrate may increase the chance for side effects, especially when kidney disease is present

• HMG-CoA reductase inhibitors (atorvastatin [e.g., Lipitor], cerivastatin [e.g., Baycol], fluvastatin [e.g., Lescol], lovastatin [e.g., Mevacor], pravastatin [e.g., Pravacol], simvastatin [e.g., Zocor])—Use with fenofibrate may cause muscle or kidney problems or make them worse

Other medical problems—The presence of other medical problems may affect the use of fenofibrate. Make sure you tell your doctor if you have any other medical problems, especially:

• Gallbladder disease or
• Gallstones or
• Liver disease—Fenofibrate may make these conditions worse

• Kidney disease—Higher blood levels of fenofibrate may result, which may increase the chance of side effects or make kidney problems worse