其 他 安 全 警 示
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| The United States: FDA Drug Safety Communication: revised dose limitation for Zocor (simvastatin) when taken with amiodarone (English Only) |
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This update is in follow-up to the FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury on 8 June 2011. The FDA is notifying the public that it has revised the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. In June 2011, the simvastatin dose limitation when taken with amiodarone (in which the simvastatin dose was lowered from 20 mg to 10 mg) was made in error. Unlike other interacting drugs, there were no pharmacokinetic or clinical trial data to support the simvastatin dose reduction approved with amiodarone. Therefore FDA has now determined that the simvastatin dose limitation, when taken with amiodarone, should be restored to 20 mg. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm283137.htm
In Hong Kong, there are 128 simvastatin-containing products registered and all are prescription-only drugs. The safety issue of simvastatin has been discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board on 6 September 2011. The Committee decided that the sales pack label and/or package insert of the products containing simvastatin should include the appropriate warnings. Similar news has been released by the Australia Therapeutic Goods Administration and was posted on the website of Drug Office on 7 December 2011. A letter to inform healthcare professionals was issued on the same day. As reported on 7 December 2011, the matter will be further discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, December 16, 2011
Issued at HKT 15:30
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