Other safety alerts
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| Singapore: Safety advisory on cyproterone acetate/ethinylestradiol |
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Health Sciences Authority (HSA), in consultation with its Product Vigilance Advisory Committee (PVAC), has completed its benefit-risk assessment on cyproterone acetate/ethinylestradiol (CPA/EE). New restrictions will be imposed to limit the use of this product so as to mitigate the risks of venous and arterial thromboembolism in view of the modest benefit derived from treatment with CPA/EE for conditions such as androgenetic alopecia and mild acne.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../safety_advisory_on.html
In Hong Kong, there are ten products with same ingredients registered in Hong Kong. Related news has been released by the EMA, Health Canada and TGA, and was posted on the Drug Office website on 31 January, 1 February, 6 February, 9 February and 18 May 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 31 January 2013. The Registration Committee of the Pharmacy and Poisons Board discussed the matter in the meeting in July 2013 and labelling updates are recommended for the related products to restrict the indications and strengthen the warning to increase the awareness of the risk of thromboembolism associated with the use of the drugs.
Ends/ Saturday, 4 January 2014
Issued at HKT 14:30
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