High-Dose Zocor Boosts Muscle Injury Risk: FDA

People taking the cholesterol-lowering drug should consult their doctor if problems arise, the agency says

Steven Reinberg

Steven Reinberg

Published on March 19, 2010

FRIDAY, March 19, 2010 (HealthDay News) -- People taking the highest approved doses of the cholesterol-lowering drug Zocor (simvastatin) may be at increased risk for muscle injuries, the U.S. Food and Drug Administration (FDA) warned Friday.

Although muscle pain and weakness, called myopathy, is a known side effect of all cholesterol-lowering drugs classified as statins, such as Zocor, the FDA said that people taking the 80 milligram dose face an especially high risk of developing muscle problems, including rhabdomyolysis, the most serious form of myopathy, which can lead to kidney damage, kidney failure and even death.

Reacting to the warning, Dr. Gregg Fonarow, a professor of cardiovascular medicine at the University of California, Los Angeles, said that patients shouldn't lose sight of the benefits of statin use.

"Statins, including simvastatin, have been shown to lower the risk of heart attack, strokes and premature cardiovascular deaths, and in most patients the benefits of statin treatment greatly outweigh the risks," he said.

While doses of simvastatin of 10 milligrams, 20 milligrams and 40 milligrams have side-effect profiles similar to other statin medications, the 80 milligram dose has been shown to have a higher risk of skeletal muscle injury, particularly in patients on other medications that may interact with simvastatin, Fonarow said.

"There are other statin medications which lower LDL -- bad cholesterol -- levels as well or better than the simvastatin 80 milligram dose and without the same degree of muscle injury risk," he said. "Patients should discuss with their physician which statin regimen and dosing is most appropriate for them."

The agency is advising patients taking the drug to talk with their doctors, before stopping or changing their medication.

"Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available, Dr. Eric Colman, deputy director of FDA's Division of Metabolism and Endocrinology Products, said in a statement. "It's important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy," he said.

In issuing Friday's warning, the agency took into account new data from clinical trials, observational studies, adverse event reports and prescription data.

In addition, the FDA is looking over data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), which studied heart attack, revascularization and cardiovascular death in patients taking 80 milligrams of Zocor, compared with patients taking 20 milligrams. The trial also included data on muscle injury.

Zocor is sold as generic simvastatin and also as the brand-name Zocor. In addition, the drug is sold in combination with other drugs in Vytorin and Simcor.

More information

For more information on statins, visit the U.S. National Library of Medicine.

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