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FDA Warns of Zocor Risk to Muscles

Muscle Injury Risk With Higher Zocor Doses, Certain Other Drugs
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WebMD Health News
Reviewed by Laura J. Martin, MD

March 19, 2010 -- Based on new data, the FDA today warned that higher doses of the cholesterol-lowering drug Zocor, sold generically as simvastatin, carry an increased risk of muscle injury.

The FDA also warns that mixing Zocor with certain other drugs also increases patients' risk of muscle injury, including the rare but serious complication known as rhabdomyolysis. Rhabdomyolysis can sometimes result in fatal kidney damage.

The combination products Vytorin and Simcor also contain simvastatin, the active ingredient in Zocor. Zocor is a member of the class of drugs known as statins. All statin drugs carry a risk of muscle damage, but new data suggest that this risk may be particularly high for the 80 milligram dose of Zocor.

The data come from the SEARCH study, in which muscle damage was seen in nearly 1% of patients taking the 80 milligram dose of Zocor but in only 0.02% of patients taking the 20 milligram dose of Zocor.

Rhabdomyolysis was rare in the SEARCH study. It happened in only 11 of 6,031 patients (0.02%) in group taking the 80 milligram dose of Zocor, but was not seen in patients taking the 20 milligram dose.

A different study found that muscle damage was more common in patients taking Zocor doses of more than 20 milligrams a day who also took the heart rhythm drug amiodarone (brand names Cordarone, Pacerone). Patients taking another drug, verapamil (brand names Calan, Covera, Isoptin, Verelan), also should not take Zocor at doses higher than 20 milligrams .

And patients taking the angina/blood pressure drug diltiazem (brand names Cardizem, Cartia, Dilacor, Diltia, and Tiazac) were also at higher risk of muscle injury if they also took Zocor at doses higher than 40 milligrams a day.

New data also suggest that people of Chinese descent should not take Zocor at the 80 milligram dose -- and should be careful even when taking lower doses -- if they also take niacin-containing products.

You should never take Zocor at any dose if you are taking:

  • Itraconazole
  • Ketoconazole
  • Erythromycin
  • Clarithromycin
  • Telithromycin
  • HIV protease inhibitors
  • Nefazodone 

You should never take more than the 10 milligram dose of Zocor if you are taking:

  • Gemfibrozil
  • Cyclosporine
  • Danazol

 

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Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

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Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.

Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.

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