FDA: High Doses of Zocor Can Be Harmful

If you take a statin to lower your cholesterol, chances are your doctor has warned you to be alert for unusual muscle pain. Now the Food and Drug Administration (FDA) is recommending that doctors limit prescriptions of the highest approved dose of the most popular statin, Zocor (simvastatin).

The FDA said patients taking an 80-milligram daily dose have an increased risk of myopathy – muscle damage – compared to patients taking lower doses or similar drugs.

The risk appears to be highest during the first year and is often the result of interactions with other drugs.

The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal.

FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.

Zocor, made by Merck, and its generic versions are the sexcond-most-popular prescriptions drugs in the U.S. Zocor was prescribed 94 million times in 2010.