其 他 安 全 警 示
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| The United States: Birth control pills containing drospirenone: possible increased risk of blood clots(English Only) |
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FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.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 venous thromboembolism (VTE) has already been included in the current package insert of the above three products. The above safety news has been released by UK Medicines and Healthcare products Regulatory Agency and was posted on the website of Pharmaceutical Service on 28 May 2011. Department of Health will keep vigilance against any new safety information related to the drugs, and the issue will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, June 1, 2011
Issued at HKT 12:30 |
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