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| Singapore: Importance of assessing renal function in patients treated with Pradaxa (dabigatran etexilate) (English Only) |
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Boehringer Ingelheim would like to inform healthcare professionals of new recommendations to assess renal function in patients being treated with or being considered for treatment with Pradaxa. Although the rate of reported suspected fatal bleeding associated with Pradaxa as of 31 October 2011 is lower than the fatal bleeding incidence of 230 events per 100,000 patient years seen in the key pre-market clinical study evaluating the efficacy of Pradaxa, RE-LY, these new recommendations have been issued to mitigate the risk of serious bleeding events arising from the use of Pradaxa in patients with varying degrees of renal impairment. The recommendations include renal assessment through creatinine clearance calculation prior to initiation of Pradaxa treatment, on-treatment renal assessment in cases of suspected renal function deterioration as well as annual on-treatment renal assessment for the elderly and patients with moderate renal impairment. The package insert of Pradaxa will be updated with the relevant information.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information/DHCPL.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 Therapeutic Goods Administration, the European Medicines Agency and the US Food and Drug Administration 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/ Friday, December 16, 2011
Issued at HKT 15:30
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