Other safety alerts
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| Australia: Oral contraceptives containing drospirenone (Yaz and Yasmin) |
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The TGA is aware of two recently published studies that reported a greater risk of blood clots, also known as venous thromboembolism (VTE) in women taking oral contraceptives containing the progestogen drospirenone when compared to oral contraceptives containing the progestogen levonorgestrel. Oral contraceptive pills registered for use in Australia that contain drospirenone are Yaz and Yasmin. The TGA has reviewed the available information and has assessed the risks of VTE associated with drospirenone-containing oral contraceptives. The TGA has been working with the sponsor to amend the product information to incorporate this new evidence. The published studies suggest a two- to three-fold increase in the risk of VTE in women who take drospirenone-containing oral contraceptives when compared to women taking contraceptives containing the progestogen levonorgestrel; however there were a number of limitations in these studies, including a lack of information on confounding factors. At this stage, the TGA has no plans to remove or restrict the sale of these products from the Australian market. However, the TGA will continue to closely monitor and assess all new information and will take whatever regulatory action is required to protect the safety of consumers. The TGA will also communicate any safety concerns to the public as it becomes available.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-oral-contraceptives-110706.htm
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 and the US Food and Drugs Administration and was posted on the website of Pharmaceutical Service on 28 May 2011 and 1 June 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/ Thursday, July 7, 2011
Issued at HKT 12:30
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