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FDA MedWatch- Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) - Report Of SEAS Trial Of A Possible Association Between The Use Of Vytorin And A Potential Increased Incidence Of Cancer
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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 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.

Read the complete MedWatch 2008 Safety Summary, including a link to the '"Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin); Simvastatin (marketed as Zocor); and Ezetimibe (marketed as Zetia)", at:

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Posts: 7,476
Reply with quote  #2 
Wow. Thank you for posting this.
It seems the longer a drug is on the market the more bad we hear about it.




Goddess Forever
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Reply with quote  #3 

So the Zocor I am taking to keep my cholesterol down from the Femara I am taking to keep from getting bc again is going to give me cancer. Does that about sum it up? Lovely.

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