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Bleeding Reports Prompt Pradaxa Label Changes in Canada

Mar 21, 2012 | Parker Waichman LLP

Reports of Pradaxa bleeding side effects have prompted regulators in Canada - where it is sold as Pradax - to add new warnings to its label regarding use of the drug in kidney patients.  New information will also be added to address use of Pradaxa in patients with severe valvular disease or prosthetic heart valves.

According to a notice from Health Canada, the Pradax patient monograph will now include new recommendations to assess renal function in patients being considered for, or already being treated with Pradax.

The Health Canada notice also pointed out 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 is also 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, the agency said.

Finally, Health Canada reminded that Pradax is contraindicated in patients with severe kidney impairment, and should not be used in patients who are at risk for bleeding. Pradax patients should be watched for signs of bleeding or anemia.   Treatment with Pradax should be discontinued should severe bleeding occur and the source of bleeding investigate, Health Canada said.

According to Health Canada, the Pradaxa label changes were ordered due to post-marketing reports of serious bleeding among elderly and patients at high risk of bleeding or patients with renal impairment being treated with the drug. As we've reported in the past, Pradaxa bleeding has no antidote.   Late last year, the maker of the drug confirmed that it had received 260 reports of bleeding-related deaths in patients taking Pradaxa since March 2008. 

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