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Published on Jun 10, 2011 by Edgar Snyder

FDA Restricts Use of 80-mg Zocor (Simvastatin) Due to Risk of Muscle Damage

limited use of Zocor

Special Alert – The Food and Drug Administration (FDA) is recommending limited use of 80-mg doses of Zocor and prescription medications containing simvastatin due to recent research that indicates a risk of muscle injury.

Drugs containing simvastatin are considered 'statins' and are used to lower the amount of bad cholesterol (low-density lipoprotein, or LDL) in the blood stream. Statins are some of the most commonly prescribed drugs in the United States, with more than 46 million prescriptions filled per year.

The 80-mg dose is the highest approved dose of simvastatin and has been shown to lower cholesterol levels 6% more than the 40-mg dose. It is sold under the brand name Zocor as a single-ingredient drug and is found in Vytorin and Simcor. More than two million people were prescribed one of these drugs in 2010.

Clinical trial data has shown that, while all statins can cause unexplained muscle weakness or pain (called myopathy), the risk is much greater for patients who take 80-mg of simvastatin – especially within the first 12 months.

The FDA has revised the drug labels to include the restrictions for the 80-mg dose of simvastatin and says that it should only be taken by patients who have been on the drug for over a year without side effects.

If patients are currently taking 40-mg doses of the drug and still have high cholesterol, physicians are advised to prescribe a different statin instead of raising the dosage amount. However, those currently prescribed a statin should not stop taking it without consulting their doctor.

During the next year, the FDA will continue to monitor the 80-mg dose before deciding whether or not to remove the prescription from the market.

"FDA: Limit Use of 80-mg Simvastatin." FDA Consumer Updates. June 9, 2011.
"FDA Recommends Limits to High-Dose Zocor." ABCNews.com. June 9, 2011.
"FDA Restricts Use of High Doses of Cholesterol-Lowering Drug Zocor." Time. June 9, 2011.
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