Other safety alerts
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| Canada: Pradax (dabigatran etexilate) - Updated Labelling Regarding Kidney Function Assessment and Use in Patients with Certain Types of Heart Valve Disease or Artificial Heart Valves |
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Boehringer Ingelheim (Canada) Ltd., in consultation with Health Canada, would like to inform healthcare professionals of important new recommendations which have been added to the Product Monograph for Pradax® (dabigatran etexilate). The updates are based on post-marketing reports of serious bleeding and the use of Pradax® in the elderly and patients at high risk of bleeding or patients with renal impairment. The updates now include new recommendations to assess renal function in patients being considered for, or already being treated with Pradax® and are as follows: a. prior to initiation of treatment with Pradax®, renal function should be assessed in all patients by calculating the creatinine clearance (CrCl) to exclude patients with severe renal impairment (i.e. CrCl < 30 mL/min), b. while on treatment with Pradax®, renal function should be assessed in clinical situations when it is suspected that renal function could decline or deteriorate rapidly, such as hypovolemia, dehydration, and with certain co-medications. These clinical situations may result in an increase of dabigatran exposure, and c. in the elderly (> 75 years), or in patients with moderate renal impairment (CrCl 30-50 mL/min), renal function should be assessed routinely by calculating the creatinine clearance at least once a year. Healthcare professionals are also reminded that the safety and efficacy of Pradax® have not been studied in patients with hemodynamically significant rheumatic valvular heart disease, especially mitral stenosis, or patients with prosthetic heart valves. There are no data to support that Pradax® provides adequate anticoagulation in patients with prosthetic heart valves, with or without atrial fibrillation. Therefore, the use of Pradax® is not recommended in patients with hemodynamically significant rheumatic valvular heart disease or in patients with prosthetic heart valves.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/pradax_hpc-cps-eng.php
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 has been released by the Australia TGA, the EMA, the US FDA and Singapore HSA and was 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 previously, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, March 22, 2012
Issued at HKT 12:30
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