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Drugs
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Ezetimibe/Simvastatin (marketed as Vytorin) Information
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.
To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.
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Related Information
- Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)
1/8/2009 - Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) - FDA Investigates a Report from the SEAS Trial (8/21/08)
8/21/2008 - Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)
1/25/2008 - Information for Healthcare Professionals - Simvastatin (marketed as Zocor and generics), Ezetimibe/Simvastatin (marketed as Vytorin), Niacin extended-release /Simvastatin (marketed as Simcor), used with Amiodarone (Cordarone, Pacerone)
The FDA notifies the public of the risk of a rare condition of muscle injury called rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. (8/8/2008) - Information on Simvastatin/Amiodarone
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Labeling and Regulatory History from Drugs@FDA
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Consumer Information
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Contact Us
Report a Serious Problem
- 1-800-332-1088
- 1-800-FDA-0178 Fax
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787
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