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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[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.
Fluvastatin is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and certain other fatty substances in the blood. Fluvastatin 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 other fats along the walls of the arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to the heart, brain, and other parts of the body. Lowering blood levels of cholesterol and other fats may help to decrease your chances of getting 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.
Fluvastatin comes as a capsule and an extended-release (long-acting) tablet to take by mouth. The capsule is usually taken with or without food once a day at bedtime or twice a day. The extended-release tablet is usually taken once a day at bedtime with or without food. Take fluvastatin 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 fluvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the extended-release tablets whole; do not split, chew, or crush them.
Your doctor may start you on a low dose of fluvastatin and gradually increase your dose, not more than once every 4 weeks.
Continue to take fluvastatin even if you feel well. Do not stop taking fluvastatin without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking fluvastatin,
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 has been more than 12 hours since your last dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
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.
Fluvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
Fluvastatin 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].
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 your treatment to check your body's response to fluvastatin.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking fluvastatin.
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.
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Last Revised -
08/01/2008
AHFS® Consumer Medication Information. © Copyright, 2008. 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.
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Page last updated: 23 December 2008 |