WEDNESDAY, June 8 (HealthDay News) -- The U.S. Food and Drug Administration has notified consumers and health care providers of safety label changes to simvastatin (Zocor), as the highest approved dose of the drug (80 mg) has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.
Simvastatin is indicated for the treatment of elevated low-density lipoprotein cholesterol (LDL-C) in combination with diet and exercise. The FDA is recommending that the 80 mg dose of the drug be used only in patients who have been taking the dose for 12 months or more and have not experienced any muscle toxicity. The drug should not be prescribed to new patients at the 80 mg dose, according to the agency. In addition, there are new contraindications and dose limitations for using simvastatin with certain medicines.
Based on the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA's Adverse Event Reporting System, the FDA decided to make changes to the safety label of simvastatin. Data reviewed revealed that the 80 mg daily dose of simvastatin was associated with an increased risk of muscle injury as compared with lower doses of simvastatin or other statin drugs. Simvastatin is commercially available as a single agent as well as in combination products that include ezetimibe or niacin.
According to a press release from the agency, "the FDA has revised the drug labels for simvastatin and Vytorin to include the new 80 mg dosing restrictions. The agency also revised the labels for simvastatin, Vytorin and Simcor to include new dosing recommendations when these drugs are used with certain medications that interact to increase the level of simvastatin in the body, which can increase the risk for myopathy. Patients who are unable to adequately lower their level of LDL-C on simvastatin 40 mg should not be given the higher 80 mg dose of simvastatin; instead, they should be placed on an alternative LDL-C-lowering treatment(s)."
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