其 他 安 全 警 示
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| Singapore: Bleeding events associated with dabigatran etexilate (Pradaxa®) (English Only) |
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The Health Sciences Authority (HSA) would like to alert healthcare professionals to serious cases of bleeding associated with the use of dabigatran and to remind healthcare professionals to closely monitor patients who are prescribed this medication, especially those with renal impairment, as well as elderly patients. The Japanese MHLW had issued a safety advisory to warn of the potential for adverse events with dabigatran (Pradaxa®), following the death of five patients who were the drug. Two clinical cases of major bleeding events in elderly patients were also published in the Archives of Internal Medicine in August 2011. Healthcare professionals are reminded of the contraindications for use stated in the local package insert as well as to maintain close clinical surveillance for signs of bleeding or anaemia is recommended throughout the treatment period, especially in patients with risk factors for bleeding.
Please refer to the following website in HAS for details:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information/product_safety_alerts/safety_alerts_2011/bleeding_events_associated.html
In Hong Kong, dabigatran is registered under the brand name of Pradaxa as 75mg, 110mg and 150mg capsules by Boehringer Ingelheim (HK) Ltd., and is a prescription-only medicine. The news have been released by the Australia TGA, the European Medicines Agency, the US FDA and Singapore HSA and were posted on the website of Drug Office in August, October, November and December 2011. Letters to inform healthcare professionals were issued in August and November 2011. As reported on 19 November 2011, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, December 28, 2011
Issued at HKT 15:30
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