Other safety alerts
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| Australia: Dabigatran (Pradaxa) & the risk of bleeding: new recommendations for monitoring kidney function |
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On 5 October 2011, the TGA published a safety advisory on the risk of bleeding relating to the use of dabigatran (Pradaxa). The TGA now advises health professionals and consumers that, following further evaluation of international reports of bleeding with Pradaxa, new recommendations for assessing kidney function before starting this medicine and during its use are now in place. Summary of the new recommendations are: (i) kidney function should be assessed in all patients prior to beginning Pradaxa therapy, (ii) patients with severe kidney impairment (i.e. CrCL<30 mL/min) should not take Pradaxa, (iii) while on treatment kidney function should be assessed in clinical situations where a decline in kidney function is suspected. Such situations include low blood volume, dehydration and when certain medications are taken at the same time, and (iv) in elderly patients (> 75 years) or in patients with moderate kidney impairment, kidney function should be assessed at least once a year. The sponsor of Pradaxa in Australia, Boehringer-Ingelheim Pty Limited, is writing to health professionals to advise them of these new recommendations and the TGA is working with the sponsor to update the Product Information and Consumer Medicine Information. These new documents will be available on the TGA website shortly.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-dabigatran-111103.htm
In Hong Kong, 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 notified by the company on 19 August 2011. The news was posted on the website of Drug Office and a letter to inform healthcare professionals was issued on the same day. TGA has released such news and it was posted on the website of Drug Office on 6 October 2011. In view of TGA's new recommendations, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, November 4, 2011
Issued at HKT 15:30
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