Other safety alerts
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| The United States: Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots |
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FDA notified healthcare professionals of release of the final report of the FDA-funded study that evaluated the risk of blood clots in users of several different hormonal contraceptives. The link is provided below. FDA’s review of the results of this study, specifically those results related to drospirenone-containing birth control pills, will be presented and discussed at the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011.
Please refer to the following website in FDA for details:
1.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm
2.http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf
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 MHRA, the US FDA, Australia TGA and Health Canada, and was posted on the website of Drug Office. 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, October 28, 2011
Issued at HKT 12:30
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