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| Canada: Yasmin and Yaz (drospirenone) - updated information on increased risk of blood clots (English Only) |
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Further to the notification posted on 16 July 2011, Health Canada would like to inform healthcare professionals a safety review of drospirenone-containing oral contraceptives (marketed under the brand names Yasmin and Yaz) with respect to the risk of blood clots (venous thromboembolism, or VTE) has been completed. The review determined that drospirenone-containing birth control pills may be associated with a risk of blood clots that is 1.5 to 3 times higher than other birth control pills. Blood clots are a rare but well known side effect associated with all birth control pills. The risks of blood clots are higher with pregnancy and childbirth than with oral contraceptives. As part of its review, Health Canada considered several recent observational studies evaluating the risk of blood clots with drospirenone-containing oral contraceptives versus other oral contraceptives. Overall, the body of current evidence suggests that the risk of blood clots is 1.5 to 3 times higher with oral contraceptives that contain drospirenone relative to those that contain levonorgestrel, a different hormone. Overall the risk of blood clots with any oral contraceptive (including Yasmin and Yaz) is very small. The drug labels for Yasmin and Yaz have been updated to include information on the studies and the recommendation that, when prescribing an oral contraceptive, health professionals consider the risks and benefits of drospirenone-containing oral contraceptives for a specific patient in light of her risk for developing blood clots, and relative to the risks and benefits of other birth control pills on the market.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_164-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 venous thromboembolism (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, Australia Therapeutic Goods Administration, Health Canada and Singapore Health Sciences Authority, and was posted on the website of Drug Office in May 2011, June 2011, July 2011, September 2011 and October 2011. 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 appropriate warnings in the sales label and/or package insert. Department of Health will keep vigilant against any updated safety issue of the drug.
Ends/ Friday, December 9, 2011
Issued at HKT 12:30
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