WASHINGTON, June 9 (UPI) -- The U.S. Food and Drug Administration said Thursday it is requiring safety label changes for the cholesterol-lowering drug, simvastatin, or Zocor.
Simvastatin is used in concert with diet and exercise to reduce the amount of the low-density lipoprotein or "bad" cholesterol. The highest approved dose of simvastatin -- 80 milligrams -- has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use, FDA officials say.
The FDA recommends 80 mg of simvastatin be used only by patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity, but it should not be prescribed to new patients.
"The FDA has completed its review of the safety of high-dose simvastatin and is making label changes to reduce the risk of statin-associated muscle injury," Dr. Eric Colman, of the FDA's Center for Drug Evaluation and Research, says in a statement. "We want to ensure that patients and healthcare professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80 mg dose of simvastatin."