其 他 安 全 警 示
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| Canada: Health Canada reviewing safety of drospirenone-containing oral contraceptives (Yasmin and Yaz) and risk of venous thromboembolism (English Only) |
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Health Canada informs that it is conducting an ongoing safety review of drospirenone-containing oral contraceptives to evaluate the potential for an increased risk of venous thromboembolism (VTE, which are blood clots) relative to other birth control pills. Blood clots are a rare but well known side effect associated with all birth control pills. They will take appropriate action as necessary once the review is complete.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_74-eng.php
In Hong Kong, there are three registered products containing drospirenone. They are Yasmin Tab (HK-48905), Angeliq Tab (HK-53676) and Yaz Tab (HK-56563) and all are registered by Bayer Healthcare Ltd. The risk of VTE has already been included in the current package inserts of the three products. The above safety news has been released by the UK Medicines and Healthcare products Regulatory Agency, the US Food and Drugs Administration and Australia Therapeutic Goods Administration and was posted on the website of Pharmaceutical Service on 28 May 2011, 1 June 2011 and 7 July 2011 respectively. The issue was discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board on 15 June 2011. The Committee decided that products containing drospirenone that were used as combined oral contraceptives (COCs) should include the following information in the sales label and/or package insert: the risk of VTE for COCs that contain drospirenone is higher than the risk for levonorgestrel-containing second general COCs, and may be similar to the risk for desogestrel-containing or gestodene-containing third generation COCs.
Ends/ Saturday, July 16, 2011
Issued at HKT 12:30
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