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FDA CONSUMER HEALTH INFORMATION - Limit Use of 80 mg Simvastatin

SILVER SPRING, Md., June 8, 2011 /PRNewswire-USNewswire/ -- The Food and Drug Administration (FDA) is recommending that the use of drugs containing 80 mg of simvastatin — the highest approved dose of the popular cholesterol-lowering statin — be sharply curtailed because of the risk of muscle injury.


FDA says this dose should only be used by patients who have been taking it for 12 months or longer without ill effect. If health care professionals find that patients now taking 40 mg of simvastatin aren't meeting their LDL cholesterol goal, FDA is advising them to choose a different statin rather than raising the simvastatin dose to 80 mg.

All statins, despite their proven benefit in lowering the risk of heart attacks and strokes, carry some risk of an injury called myopathy, characterized by unexplained muscle weakness or pain. But the risk is greater for patients who take the 80 mg doses of simvastatin, especially in the first year of treatment.

Learn more about the FDA's concerns about the risk of taking this high-dose statin at

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SOURCE U.S. Food and Drug Administration
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