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Label Change for Cholesterol-Lowering Drug Zocor, Recommending Lower Maximum Dose
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The FDA announced today safety label changes for the cholesterol-lowering medication simvastatin, brand name Zocor, because the highest approved dose -- 80 milligram (mg) -- has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.
The FDA now recommends that simvastatin 80 mg be used only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. It should not be prescribed to new patients. There are also new contraindications and dose limitations for when simvastatin is taken with certain other medications.
The label changes are based on the FDA's review of the results of a seven-year clinical trial, along with other clinical trial data and adverse events reported to the agency. All showed that patients taking simvastatin 80 mg daily had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statin drugs. The risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin, is often the result of interactions with certain other medicines, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury.
Simvastatin is sold under the brand-name Zocor and as a single-ingredient generic product. It is also sold in combination with ezetimibe as Vytorin, and in combination with Niacin as Simcor.
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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Posted By DeCarli Law on
June 08, 2011 12:23 pm |
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