其 他 安 全 警 示
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| The United States: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events (English Only) |
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FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs. FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa. At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label. Patients with atrial fibrillation should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death. FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm
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 information on the risk of bleeding has been released by the Australia Therapeutic Goods Administration and the European Medicines Agency and was posted on the website of Drug Office on 19 August, 6 October, 4 November and 19 November 2011. Letters to inform healthcare professionals were issued on 19 August and 4 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/ Thursday, December 8, 2011
Issued at HKT 15:30
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