新聞及資訊

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

Related Information:

The United Kingdom: Direct-acting oral anticoagulants (DOACs): reminder of bleed... 上載於 2020-06-30

澳洲：新口服抗凝血劑 - 阿哌沙班(Eliquis)、達比加群(Pradaxa)及利伐沙班(Xarelto) - 此時沒有證據支持常規監測血液上載於 2015-06-04

美國：Pradaxa(達比加群)：藥物安全通訊：導致中風和死亡的風險較華法林低，但胃腸道出血風險較華法林高上載於 2014-05-14

新加坡：更新新口服抗凝血劑的標籤以減低出血的風險上載於 2014-04-26

英國：新口服抗凝血劑Eliquis、Pradaxa及Xarelto：慎防出血的風險因素及注意產品的用法用量、使用的警告及注意事項以減低出血的風險上載於 2013-10-05

澳洲：安全建議：阿哌沙班(Eliquis)、達比加群(Pradaxa)及利伐沙班(Xarelto)：出血的風險因素上載於 2013-09-25

澳洲：達比加群(Pradaxa)可導致出血風險上載於 2013-05-24

加拿大衞生部：Pradaxa（達比加群，舊稱Pradax）不可用於植有人工心瓣的患者上載於 2012-12-22

歐洲聯盟：人用藥物委員會(CHMP)接納有關Pradaxa（達比加群酯）新增禁忌症的建議:服用抗凝血劑的人工心臟瓣膜患者上載於 2012-12-15

美國：Pradaxa（達比加群酯甲磺酸鹽）：藥物安全通訊 — 對上市後報告嚴重出血事件展開的安全審核（更新）上載於 2012-11-03

歐洲聯盟：歐洲藥物監管局更新有關Pradaxa的資訊 — 相關資料確認抗凝血藥Pradaxa的利益與風險平衡為正面，但產品資訊應作修定以給予更清晰的指引以助減低... 上載於 2012-05-26