Other safety alerts
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| Singapore: Safety update on statins |
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The HSA would like to draw the attention of healthcare professionals to important new safety information related to the class of statin products. The US Food and Drug Administration (FDA) has announced several safety updates to the product labels of statin-containing products, including warnings on cognitive side effects and reports of increased blood glucose and glycosylated haemoglobin (HbA1c) levels. An increased risk of myopathy and rhabdomyolysis with high dose simvastatin (80mg) was also confirmed following a re-analysis of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. Healthcare professionals are advised to take into consideration the above safety issues when prescribing statins to their patients.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../Safety_Alerts_2012.html
In Hong Kong, there are about 241 registered pharmaceutical products which belong to the classes of statins and are prescription-only medicines. News related to statins has been released by FDA and TGA 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 and 3 March 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 regarding statins will be further discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, August 30, 2012
Issued at HKT 14:00 |
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