ADR that result in revision of patient information
|
| |
| Canada: Zocor® (simvastatin) - New Safety Recommendations on Dosage Associated with the Increased Risk of Myopathy/Rhabdomyolysis |
| |
Health Canada endorsed important safety information on Zocor® regarding the new safety recommendations on dosage associated with the increased risk of myopathy/rhabdomyolysis. The regular use of the 80 mg dose of simvastatin has been associated with an increased risk of myopathy/rhabdomyolysis, particularly during the first year of treatment. An increased risk of myopathy/rhabdomyolysis within the recommended dose range for Zocor® can also be seen with concomitant administration of certain medications. Health Canada advised that:
1. The recommended simvastatin dosage is 5 to 40 mg/day. Patients unable to achieve their LDL-C goal with the 40 mg dose of Zocor® should be switched to alternative LDL-C-lowering treatments with lower risks of muscle toxicity.
2. Simvastatin 80 mg dose should be restricted to patients who have been taking this dose chronically with no evidence of muscle toxicity or to patients at high risk for cardiovascular complications who do not tolerate other statins and in whom the benefits are expected to outweigh the potential risks.
3. Patients currently tolerating the 80 mg dose of Zocor® who need an interacting drug that is either contraindicated, such as potent inhibitors of CYP3A4, cyclosporine, danazol, and gemfibrozil, or associated with an increase of plasma level of simvastatin should be switched to an alternative statin with less potential for a drug-drug interaction.
4. Concomitant use of recommended dosage of simvastatin with certain drugs and food, such as verapamil, diltiazem, fibrates, gemfibrozil, fenofibrate, amiodarone, amlodipine, fusidic acid and grapefruit juice, also increases the risk of myopathy/rhabdomyolysis, therefore various dosage of simvastatin is recommended.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/../zocor_hpc-cps-eng.php
In Hong Kong, there are 121 simvastatin-containing products registered and all are prescription-only medicines. Related news has been released by the US FDA, Australia TGA and Singapore HSA and was posted on the website of Drug Office on 9 June 2011, 7 December 2011, 16 December 2011, 29 February 2012, 2 March 2012, 3 March 2012 and 30 August 2012. Letters to inform healthcare professionals were issued on 9 June 2011, 7 December 2011, 29 February 2012 and 2 March 2012. The safety issue of simvastatin has been discussed in the meeting of the 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. As reported before, the matter will be further discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, November 14, 2012
Issued at HKT 14:00
|
| |
|
