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FDA to Monitor Bleeding Events with Pradaxa

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Washington, DCThe US Food and Drug Administration (FDA) has announced that it is investigating postmarketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate) an anti-clotting drug by Boehringer Ingelheim.

A communication issued by the agency earlier this week stated, "FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa." And, "Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs."

According to a report on Heartwire bleeding events in patients taking Pradaxa have prompted safety advisories in Japan and Australia, leading to label changes for the medicine in Europe and the US. "In November, Boehringer Ingelheim confirmed that between March 2008 and October 31, 2011 there were 260 fatal bleeding events worldwide." (Heartwire)

Pradaxa is an oral direct thrombin inhibitor, approved for stroke prevention in patients with atrial fibrillation in more than 50 countries, including the U.S., Canada, Japan, and the member states of the European Union. It is also approved in some countries (not the U.S.) for the prevention of venous thromboembolism (VTE) in patients undergoing total hip or knee replacement.

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