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  • FDA Date: 03/19/2010

    Vytorin (ezetimibe/simvastatin) FDA Drug Safety Communication

    Ongoing Safety Review of High-Dose Zocor (Simvastatin) and Increased Risk of Muscle Injury

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    Based on review of data from a large clinical trial and data from other sources, FDA is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the statin class. Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin, and with niacin as Simcor.

    The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury

    Healthcare professionals should:

    - Understand that rhabdomyolysis is a rare adverse event reported with all statins.

    - Be aware of the potential increased risk of muscle injury with the 80 mg dose of simvastatin compared to lower doses of simvastatin and possibly other statin drugs.

    - Follow the recommendations in the simvastatin label regarding drugs that may increase the risk for muscle injury when used with simvastatin.

    This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.

    View the full FDA Drug Safety Communication on FDA.gov