Cautions Added to Pradax (Pradaxa) Label in Canada for Kidney, Valvular Disease, and Heart Valve Patients

Health Canada today announced that the label for Pradax (dabigatran etexilate) will be updated to include new information regarding its use in kidney patients and those with severe valvular disease or prosthetic heart valves. Pradax is sold under the name Pradaxa in the U.S.

Pradaxa, approved by the U.S. Food & Drug Administration (FDA) in October 2010, is used to prevent strokes in people with atrial fibrillation. It was expected to be adopted as a replacement for warfarin, which can have dangerous interactions with certain foods. However, in recent months, concerns have been mounting about potentially dangerous Pradaxa bleeding side effects. Unlike the bleeding that occurs with warfarin – which can be stopped via the administration of vitamin K – there is no antidote for Pradaxa bleeding.

Late last year, Boehringer Ingelheim acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa. The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects. Regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.

Health Canada announced today that the Product Monograph for Pradax is being updated in Canada due to 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. In addition, Health Canada is reminding physicians that Pradax is contraindicated in patients with severe kidney impairment, and should not be used in patients are who 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.

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.

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