A cholesterol absorption inhibitor - It can help lower blood cholesterol for patients who are at ris... more
FDA Alerts
Special Alerts:
[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/medwatch/safety/2008/safety08.htm#ezetimibe2 and http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm.
EZETIMIBE blocks the absorption of cholesterol from the stomach. It can help lower blood cholesterol for patients who are at risk of getting heart disease or a stroke. It is only for patients whose cholesterol level is not controlled by diet.
This medicine may be used for other purposes;
ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
liver disease
an unusual or allergic reaction to ezetimibe, medicines, foods, dyes, or preservatives
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. This medicine can be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can.
If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
other medicines to lower cholesterol or triglycerides
This list may not describe all possible interactions.
Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. You will need to have your cholesterol levels checked. If you are also taking some other cholesterol medicines, you will also need to have tests to make sure your liver is working properly.
Tell your doctor or health care professional if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.
You need to follow a low-cholesterol, low-fat diet while you are taking this medicine.
This will decrease your risk of getting heart and blood vessel disease. Exercising and avoiding alcohol and smoking can also help. Ask your doctor or dietician for advice.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
dark yellow or brown urine
unusually weak or tired
yellowing of the skin or eyes
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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