Caduet (combination with amlodipine), Lipitor

[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.

Atorvastatin is used along with diet, exercise, and weight-loss to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Atorvastatin is also used to decrease the amount of cholesterol (a fat-like substance) and other fatty substances in the blood. This will decrease the risk of stroke, heart attack, and other heart diseases because when there are high levels of cholesterol and other fats in the blood, these substances may build up along the walls of the blood vessels and decrease or block blood flow to the heart. Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body.

Atorvastatin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take atorvastatin at around the same time 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 atorvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of atorvastatin and gradually increase your dose, not more than once every 2-4 weeks.

Continue to take atorvastatin even if you feel well. Do not stop taking atorvastatin 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.

Atorvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• gas
• headache
• joint pain

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

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

Atorvastatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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 atorvastatin 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: antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin); digoxin (Lanoxin); diltiazem (Cardizem, Cartia,Taztia, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); efavirenz (Sustiva, in Atripla); oral contraceptives (birth control pills); other cholesterol-lowering medications such as fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (nicotinic acid, Niacor, Niaspan); certain medications used in combination for HIV such as ritonavir and lopinavir (Kaletra) and ritonavir (Norvir) taken with saquinavir (Invirase); medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune); rifampin (Rifadin, Rimactane); and spironolactone (Aldactone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver disease. Your doctor will probably tell you not to take atorvastatin.
• tell your doctor if you consume more than 2 alcoholic beverages daily and if you have or have ever hadmuscle aches or weakness; diabetes; or thyroid or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking atorvastatin, stop taking atorvastatin and call your doctor immediately. Atorvastatin may 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 atorvastatin.
• ask your doctor about the safe use of alcoholic beverages while you are taking atorvastatin. Alcohol can increase the risk of serious side effects.

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.

Avoid drinking large amounts (more than about 1 quart, 1 liter every day) of grapefruit juice while taking atorvastatin.

Take the missed dose as soon as you remember it. However, if it is less than 12 hours until your next scheduled dose, skip the missed dose and continue your 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 body's response to atorvastatin.

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

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.