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| Australia: Simvastatin - new contraindications, precautions and dosage recommendations (English Only) |
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The TGA is advising health professionals to limit the prescribing of high dose (80 mg/day) simvastatin and to be aware of new contraindications and precautions for the use of simvastatin with other medicines. The TGA recommends that 80mg/day simvastatin should only be used in patients at a high risk of cardiovascular complications who have not achieved their treatment goals on lower doses. Patients on high dose simvastatin and those taking certain other medicines have an increased risk of developing myopathy (muscle weakness) and, more rarely, rhabdomyolysis. Concomitant administration of simvastatin with the following medicines is now contraindicated: gemfibrozil, cyclosporine, danazol and potent CYP3A4 inhibitors such as itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors. Specific precautions (such as lower recommended simvastatin doses) now exist for patients taking the following medicines: moderate inhibitors of CYP3A4, amiodarone, the calcium channel blockers verapamil, diltiazem and amlodipine, fibrates other than gemfibrozil, niacin (≧1g/day) and colchicine. Simvastatin is used to control elevated cholesterol, or hypercholesterolemia. It is recommended to be used only after other measures such as diet, exercise, and weight reduction have not improved cholesterol levels. The TGA is working with the sponsors of simvastatin and simvastatin-containing products to update the Product Information.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-simvastatin-111206.htm
In Hong Kong, there are 128 simvastatin-containing products registered and all are prescription-only drugs. Similar news has been released by the US FDA and was posted on the website of Drug Office on 9 June 2011. A letter to inform healthcare professionals was issued on the same day. The matter 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. In view of TGA's recommendation, a letter to inform healthcare professionals will be issued and the matter will be further discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, December 7, 2011
Issued at HKT 17:30 |
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