Consumer Watch Group Calls For Ban of Zocor

Zocor (simvastatin) is a synthetic statin developed by Merck that is designed to lower cholesterol. Zocor is part of a class of drugs called statins that are used to treat high LDL (bad) cholesterol. Simvastatin is also sold in generic versions, and is an active ingredient in the combination drugs Vytorin and Simcor. Muscle injury has long been recognized as one of the possible Zocor side effects, and the labels of these medications all bear warnings regarding this risk. In 2010, the U.S. Food and Drug Administration (FDA) updated the labels of high-dose simvastatin to warn of an association with muscle injuries.

The FDA now says that doctors should no longer prescribe 80 milligrams of Zocor unless a patient has already been taking the dose for a year without any apparent trouble. But not everyone agrees that the warning goes far enough. Public Citizen has placed the Zocor 80 mg doses on its “Do Not Use” list, following an FDA warning about the risk of serious and potentially life-threatening muscle injury from Zocor that was issued earlier this week. The FDA announced June 8 that it is recommending that no new patients be started on an 80 mg Zocor (simvastatin) regimen, due to the risk of high dose Zocor side effects including
myopathy, rhabdomyolysis, kidney damage and other muscle injury.

The FDA's action was prompted by a seven-year study and patient reports that prove those taking the higher dosage of simvastatin have a greater risk of muscle injury than patients treated with lower doses or other statins. Merck made these changes to the prescribing information in response to an FDA review of findings from SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) and other sources.  The increased risk was observed in patients using simvastatin 80 mg compared with both lower doses of the drug and other similarly effective statin therapies. The risk was found to be highest during the first year of treatment, with notably decreased risk thereafter. The 80-mg dose of simvastatin is available as a brand-name or generic single-ingredient product and in the combination product Vytorin; the updated prescribing information will affect all these products