其 他 安 全 警 示
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| The United States: FDA announces new safety recommendations for high-dose simvastatin (English Only) |
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The U.S. Food and Drug Administration (FDA) has announced safety label changes for the cholesterol-lowering medication simvastatin 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 agency is recommending that simvastatin 80mg 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 changes to the label for simvastatin-containing medications are based on the FDA’s review of the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA’s Adverse Event Reporting System.
Please refer to the following website in the FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm
In Hong Kong, there are currently 126 simvastatin-containing products registered. A simvastatin-containing product is a prescription drug. In light of the new information, the issue will be discussed in the next meeting of Registration Committee of the Pharmacy and Poisons Board. A “Dear Healthcare Professional” letter will be issued.
Ends/Thursday, June 9, 2011
Issued at HKT 12:00
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