Simcor (as a combination product containing Niacin and Simvastatin), Vytorin (as a combination product containing Ezetimibe and Simvastatin), Zocor

[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Statin and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01892.html.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Simvastatin is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in your blood. Simvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body.

Buildup of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help to decrease your risk of heart disease, angina (chest pain), strokes, and heart attacks. In addition to taking a cholesterol-lowering medication, making certain changes in your daily habits can also lower your cholesterol blood levels. You should eat a diet that is low in saturated fat and cholesterol (see SPECIAL DIETARY), exercise 30 minutes on most, if not all days, and lose weight if you are overweight.

Simvastatin comes as a tablet to take by mouth. It usually is taken one to three times a day. Take simvastatin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take simvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of simvastatin and gradually increase your dose, not more than once every 4 weeks.

Continue to take simvastatin even if you feel well. Do not stop taking simvastatin without talking to your doctor.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Simvastatin may cause side effects. Tell your doctor if this symptom is severe or does not go away:

• constipation

If you experience the following symptoms, call your doctor immediately:

• muscle pain, tenderness, or weakness
• lack of energy
• fever
• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• nausea
• extreme tiredness
• unusual bleeding or bruising
• loss of appetite
• flu-like symptoms
• rash
• hives
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness

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 http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

• tell your doctor and pharmacist if you are allergic to simvastatin or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); anticoagulants ('blood thinners') such as warfarin (Coumadin); cholestyramine (Questran); clarithromycin (Biaxin); clofibrate (Atromid-S); cyclosporine (Sandimmune, Neoral); danazol; digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir) and saquinavir (Invirase, Fortovase); nefazodone (Serzone); other cholesterol-lowering medications such as fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (nicotinic acid, Niacor, Niaspan); telithromycin (Ketek); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have liver disease. Your doctor will probably tell you not to take simvastatin.
• tell your doctor if you drink large amounts of alcohol, if you have ever had liver disease or if you have or have ever had kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking simvastatin, stop taking simvastatin and call your doctor immediately. Simvastatin can harm the fetus.
• do not breast-feed while you are taking this medication.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking simvastatin.
• ask your doctor about the safe use of alcoholic beverages while you are taking simvastatin. Alcohol can increase the risk of serious side effects.

Avoid drinking large quantities (more than 1 quart a day) of grapefruit juice while taking simvastatin.

Eat a low-cholesterol, low-fat diet, which includes cottage cheese, fat-free milk, fish, vegetables, poultry, and egg whites. Use monounsaturated oils such as olive, peanut, and canola oils or polyunsaturated oils such as corn, safflower, soy, sunflower, cottonseed, and soybean oils. Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, pastries, cakes, cookies, gravy, peanut butter, chocolate, olives, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods.

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 the regular dosing schedule. Do not take a double dose to make up for a missed one.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your response to simvastatin.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking simvastatin.

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.