FDA: No Increased Bleeding Risk for Boehringer Ingelheim GmbH's Pradaxa

Published: Nov 02, 2012

The risk of serious bleeding among new users of Pradaxa, a blood-clot preventer made by Germany's Boehringer Ingelheim, appeared to be no higher than in patients on the widely used standard blood thinner warfarin, U.S. regulators said.

The announcement Friday by the U.S. Food and Drug Administration may allay some safety concerns about Pradaxa, a pill developed by the privately held drugmaker Boehringer, to prevent strokes among patients with an irregular heartbeat known as atrial fibrillation.

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