Notice
[Posted 3/1/2012] ISSUE: FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.
BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (''bad cholesterol''). HIV protease inhibitors are a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of prescription anti-viral drugs used to treat hepatitis C infection.
RECOMMENDATION: Healthcare professionals should follow the recommendations in the prescribing information (drug labels) when prescribing HIV or HCV protease inhibitors with statins. See the FDA Drug Safety Communication for additional information, including a data summary. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
[Posted 2/28/2012] ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels.
The lovastatin (Mevacor) label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.
Read the FDA Drug Safety Communication for more information at: http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm
BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (''bad cholesterol''). Marketed as single-ingredient products, including atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor). Also marketed as combination products, including lovastatin/niacin extended-release (Advicor), simvastatin/niacin extended-release (Simcor),and simvastatin/ezetimibe (Vytorin).
RECOMMENDATION: Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted.
Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Simvastatin is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') in the blood. Simvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Simvastatin is also used to decrease the risk of heart attacks, strokes, and death, and to decrease the need for surgery to improve blood flow in people who have medical conditions that put them at high risk of developing heart and blood vessel problems. Simvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body so that the cholesterol cannot buildup on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.
How should this medicine be used?
Simvastatin comes as a tablet to take by mouth. It usually is taken once a day in the evening. Take simvastatin 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 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.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking simvastatin,
tell your doctor and pharmacist if you are allergic to simvastatin , any other medications, or any of the ingredients in simvastatin tablets. Ask your doctor or pharmacist for a list of the ingredients.
tell your doctor if you are taking antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), and posaconazole (Noxafil); clarithromycin (Biaxin, in PrevPac); cyclosporine (Gengraf, Neoral, Sandimmune); danazol; erythromycin (E.E.S., E-Mycin, Erythrocin); gemfibrozil (Lopid); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir) and saquinavir (Invirase, Fortovase); nefazodone; and telithromycin (Ketek). Your doctor will probably tell you not to take simvastatin if you are taking these 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); amlodipine (Norvasc, in Caduet, in Lotrel); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); colchicine; digoxin (Digitek, Lanoxicaps, Lanoxin); diltiazem (Cardizem, Dilacor, Tiazac); other cholesterol-lowering medications such as fenofibrate (Tricor) and niacin (nicotinic acid, Niacor, Niaspan); ranolazine (Ranexa); verapamil (Calan, Covera, Isoptin, Verelan); and voriconazole (Vfend). 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 are 65 years of age or older, and if you are Asian, especially if you are Chinese. Also tell your doctor if you have or have ever had an underactive thyroid gland, diabetes, seizures, or kidney disease.
tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant during your treatment with simvastatin. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking simvastatin, stop taking simvastatin and call your doctor immediately. Simvastatin can harm the fetus.
tell your doctor if you are breast-feeding. You should not breast-feed while you are taking simvastatin.
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.
What special dietary instructions should I follow?
Avoid drinking large quantities (more than 1 quart [1 liter] 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 and increase the amount of soluble fiber in your diet with foods such as oatmeal, kidney beans, and apples. 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, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods. Talk with your doctor or dietitian if you have any questions or would like more information about low-fat, low-cholesterol diets.
What should I do if I forget a dose?
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.
What side effects can this medication cause?
Simvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
constipation
stomach pain
nausea
headache
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately. If you experience any of the first 7 symptoms on this list, do not take any more simvastatin without talking to your doctor:
muscle pain, tenderness, or weakness
dark red urine
decreased urination
lack of energy, tiredness, or weakness
loss of appetite
pain in the upper right part of the stomach
yellowing of the skin or eyes
fever or chills
flushing
blisters
rash
hives
itching
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
hoarseness
joint pain
sensitivity to light
This medication may cause other side effects. Call your doctor if you have any unusual problems while you are 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/Safety/MedWatch] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
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 emergency/overdose
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.
