Zocor implicated in muscle, kidney risks

The Food and Drug Administration (FDA) released a warning on Friday, implicating Zocor, a statin drug, in muscle damage as well as severe and potentially lethal kidney damage. The FDA said the risk is most severe at the highest levels of the drug.

Statin drugs are used to control cholesterol. All statin drugs have a risk of muscle damage, but the FDA said the risk was higher with the 80-mg, or highest, dose of Zocor. Zocor is also sold generically as simvastatin.

The risks include a rare form of muscle damage known as rhabdomyolysis. In rhabdomyolysis, damaged muscle tissues release a protein called myoglobin into the bloodstream. Myoglobin can damage the kidneys, lead to kidney failure, and even death.

The FDA cited a large clinical trial which compared 6,031 patients taking 80 mg. daily with 6,033 patients taking 20 mg. The study found 52 cases of myopathy in the 80-mg. group and only one in the 20-mg. group. Additionally, eleven patients in the 80-mg. group developed rhabdomyolysis, but none did so in the lower-dose group.

The risk is highest in patients of Chinese descent, and those patients should be careful even when taking lower doses, if they also take niacin-containing products.

For all patients, do not take simvastatin when using these drugs:

• erythromycin
• itraconazole
• ketoconazole
• clarithromycin
• telithromycin
• HIV protease inhibitors
• nefazodone

Patients should not take more than 10 mg. of Zocor daily with these drugs:

• gemfibrozil
• cyclosporine
• danazol

They should not take more than 20 mg. with these drugs:

• amiodarone
• verapamil

And they should not use more than 40 mg. with this drug:

diltiazem