Notice
[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.
[UPDATE 01/08/2009] The FDA has completed its review of the final clinical study report of ENHANCE and issued an update. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch and http://www.fda.gov/Drugs.
[Posted 08/21/2008] FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of ezetimibe with simvastatin (Vytorin) and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.
FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch and http://www.fda.gov/Drugs.
Why is this medication prescribed?
Ezetimibe 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 the blood. It may be used alone or in combination with an HMG-CoA reductase inhibitor (statin). Ezetimibe is in a class of medications called cholesterol-lowering medications. It works by preventing the absorption of cholesterol in the intestine.
Buildup of cholesterol and fats along the walls of the blood vessels (a process known as atherosclerosis) decreases blood flow, which decreases the oxygen supply to the heart, brain, and other parts of the body. Lowering blood levels of cholesterol and fats may help reduce this buildup and may decrease your chances of developing heart conditions such as angina (chest pain), strokes, and heart attacks. Results of a clinical study that compared people who took ezetimibe and simvastatin with people who took simvastatin alone found that although the group of people taking ezetimibe and simvastatin had lower amounts of cholesterol in the blood, there was no difference between the two groups in the amount of cholesterol and fat buildup on the insides of the blood vessels in the neck. It is not currently understood why the additional lowering of cholesterol levels in the blood did not lead to a greater decrease in cholesterol and fat buildup along the walls of the blood vessels in people taking ezetimibe and simvastatin. Further studies are underway to compare treatment with ezetimibe and simvastatin to treatment with simvastatin alone to see if there is a difference in the risk of developing heart disease. Talk to your doctor if you have questions about the risks and benefits of treating increased amounts of cholesterol in your blood with ezetimibe and other medications.
In addition to taking a cholesterol-lowering medication, making certain changes in your daily habits can also lower your blood cholesterol 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.
How should this medicine be used?
Ezetimibe comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take ezetimibe, take it 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 ezetimibe exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take ezetimibe even if you feel well. Do not stop taking ezetimibe 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 ezetimibe,
tell your doctor and pharmacist if you are allergic to ezetimibe or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants (''blood thinners'') such as warfarin (Coumadin); cyclosporine (Neoral, Sandimmune); fenofibrate (TriCor); and gemfibrozil (Lopid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
if you are taking cholestyramine (Questran), colesevelam (WellChol), or colestipol (Colestid), take it 4 hours before or 2 hours after ezetimibe.
tell your doctor if you have or have ever had liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ezetimibe, call your doctor.
What special dietary instructions should I follow?
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.
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 your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Ezetimibe may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
headache
dizziness
diarrhea
sore throat
runny nose
sneezing
joint pain
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
hives
rash
itching
difficulty breathing or swallowing
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
upset stomach
extreme tiredness
unusual bleeding or bruising
lack of energy
loss of appetite
pain in the upper right part of the stomach
yellowing of the skin or eyes
flu-like symptoms
muscle pain or weakness
fever
chills
pale or fatty stools
chest pain
Ezetimibe 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/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.
