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FDA Warns of Pradaxa Risk of Bleeding

Posted on Mar 15, 2012

The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
The 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. (See Data Summary). FDA is working closely with the manufacturer of Pradaxa (Boehringer Ingelheim) to evaluate the post-market reports of bleeding.FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.


Call your healthcare professional and seek immediate care if you develop any signs or symptoms of bleeding such aunusual bleeding from the gum,nose bleeding that happens oftenmenstrual or vaginal bleeding that is heavier than normal, bleeding that is severe or you cannot control, pink or brown urine, red or black stools (looks like tar), bruises that happen without a known cause or that get larger, coughing up blood or blood clots, vomiting blood or vomit that looks like coffee grounds.
Discuss any questions or concerns about Pradaxa with your healthcare professional.

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