Entries in Simvastatin (1)


FDA Recommends Limits to High-Dose Zocor for Cholesterol

Keith Brofsky/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration has recommended limiting high doses of a widely prescribed cholesterol-lowering drug called simvastatin -- commonly known as Zocor -- after reviewing the results of a clinical trial that found a higher risk of muscle damage compared to patients taking lower doses of the statin.

The use of the 80-mg dose of Zocor, the highest approved dose of the drug, can harm muscles and potentially cause deadly kidney damage, the U.S. Food and Drug Administration warned Wednesday.

More than 2 million Americans were prescribed the 80-mg dose of Zocor or another type of simvastatin in 2010, according to the FDA. Simvastatin is also sold as the combination statin drugs Vytorin or Simcor.

The most common side effects of Zocor include muscle pain, tenderness and weakness. While rare, more serious side effects include muscle damage that can lead to liver disease and kidney failure. Five out of every 100,000 people taking Zocor for a year experienced the effects, according to the FDA.

Statins, including Zocor, have been shown to dramatically lower bad cholesterol in patients with heart disease and diabetes. But many doctors say they've known long before this warning of its potential dangers. And, some said, an FDA recommendation for a warning label is a necessary next step.

About 13 million people in the United States take statins to lower cholesterol levels and reduce the risk of heart disease. Many doctors said they switch to other kinds of statins, including Crestor and Lipitor, if a patient required a higher dose. The drugs were not among those shown to raise the risk of muscle damage.

Only patients who have been taking the 80-mg dose for 12 months or longer without signs of muscle damage should continue to take Zocor, the FDA recommended.

Patients should not stop taking their medication unless told by a doctor to do so.

Copyright 2011 ABC News Radio

ABC News Radio