其他安全警示

Australia: Dabigatran (Pradaxa): risk of bleeding relating to use (English Only)

In April 2011, the Therapeutic Goods Administration (TGA) approved the use of Pradaxa to prevent stroke and other blood clots in people with atrial fibrillation (AF), a commonly occurring abnormal heart rhythm. As with warfarin, another oral anticoagulant, there is a risk of bleeding when using this medicine. Since more people have started to use Pradaxa, the TGA has received an increase in the number of bleeding-related adverse events reports. The TGA analysis of these reports shows that: (i) some of the bleeding adverse events occurred during the transition from warfarin to dabigatran, (ii) many of the adverse events are occurring in patients on the reduced dosage regimen, and (iii) the most common site of serious bleeding for Pradaxa is the gastrointestinal tract, whereas for warfarin it is intracranial. In clinical trials the risk of bleeding per year of treatment with Pradaxa was 16.6% (1 in 6 patients) when taking 150 mg twice daily, and 14.7% (1 in 6.8 patients) taking 110 mg twice daily compared to 18.4% (1 in 5.4 patients) for warfarin. Clinicians are urged to give careful consideration to the suitability of their patients for Pradaxa, particularly with regard to the risks of bleeding and their current stability on warfarin or other anticoagulants.
Please refer to the following website in TGA for details: http://www.tga.gov.au/safety/alerts-medicine-dabigatran-111005.htm

In Hong Kong, dabigatran is registered under the brand name of Pradaxa as 75mg, 110mg and 150mg capsules by Boehringer Ingelheim (HK) Ltd. Pradaxa is an anticoagulant and is a prescription-only medicine. The package insert has been updated to include the above warnings. The information on the risk of bleeding has been notified by Boehringer Ingelheim (HK) Ltd. on 19 August 2011. The news was posted on the website of Pharmaceutical Service and a letter to inform healthcare professionals was issued on the same day.

Ends/ Thursday, October 6, 2011
Issued at HKT 12:30

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