Other safety alerts
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| Australia: Safety advisory: Warfarin review |
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Consumers and health professionals are advised that the TGA has completed a review of the Product Information (PI) for goods containing warfarin. Warfarin is an anticoagulant that is used for the prevention and treatment of problems associated with blood clots including venous thrombosis and pulmonary embolism, and some heart conditions in which blood vessels become blocked.
The review involved evaluation of the PIs and relevant medical literature, and expert advice from the Advisory Committee on the Safety of Medicines. The TGA found that the PI for warfarin required an update for clarity and inclusion of important clinical information. Proposed changes relate to potential drug interactions, patient monitoring for anticoagulant status and treatment of overdose. The TGA is working with the sponsor to update the PI to provide clearer and more up-to-date information. Further details of the proposed changes to the PI will be provided in a future alert.
Consumers are reminded that warfarin may interact with other medications, including herbal/complementary medicines. These interactions may result in serious bleeding events. Frequent monitoring is required.
Health professionals are reminded that the safety of warfarin is maintained by frequent monitoring of the International Normalised Ratio. The major causes of bleeding with warfarin include the concomitant use of antiplatelet agents, anticoagulants and non-steroidal anti-inflammatory drugs, and concomitant use of medicines that alter the metabolism of warfarin.
Please refer to the following website in TGA for details:
https://www.tga.gov.au/alert/warfarin-review
In Hong Kong, there are 15 registered pharmaceutical products containing warfarin. All of them are prescription-only medicines. So far, the Department of Health (DH) has not received any adverse drug reaction report related to warfarin. In view of the TGA's announcement that further details of the proposed changes to the PI of the products will be provided in a future alert, the DH will keep vigilant on the updates from the TGA and other overseas health authorities for consideration of any action deem necessary.
Ends/ Tuesday, February 17, 2015
Issued at HKT 13:00
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