其 他 安 全 警 示
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| Japan: Safety advisory issued by the Japanese Ministry of Health, Labour and Welfare regarding Pradaxa (dabigatran etexilate) (English Only) |
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The Department of Health has been informed by Boehringer Ingelheim (HK) Ltd. (BI) that Japanese Ministry of Health, Labour and Welfare (MHLW) has issued a safety advisory warning of the potential for adverse events with Pradaxa (dabigatran etexilate).
In a safety advisory meeting, the MHLW noted that there have been 81 cases of serious side effects, including gastrointestinal bleeding, since the launch of dabigatran in Japan. The drug has been used in around 64 000 people between approval in January and 11 August 2011. Within this group, treatment of Pradaxa could not be ruled out as a cause of death in five patients, one of whom had kidney failure and four of them were aged over 80.
BI informed that as of today, 6 Japanese cases with haemorrhagic events with fatal outcome have been identified. The 6th case was identified recently and is not included in the MHLW’s analysis.
In Hong Kong, Pradaxa is registered as 75mg, 110mg and 150mg capsules by Boehringer Ingelheim (HK) Ltd. Pradaxa is an anticoagulant and is a prescription drug. In light of MHLW’s safety advisory, letter to inform Healthcare Professionals will be issued.
Ends/ Friday, August 19, 2011
Issued at HKT 12:30
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