First Pradaxa Side Effects Lawsuits Filed | Houston Chronicle

The FDA is now investigating post-marketing reports of serious bleeding events and deaths in patients taking Pradaxa (dabigatran etexilate).

Pradaxa was approved in October 2010 by the FDA for the prevention of stroke in patients with non-valvular atrial fibrillation. Atrial fibrillation is the most comm

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Pradaxa was approved in October 2010 by the FDA for the prevention of stroke in patients with non-valvular atrial fibrillation. Atrial fibrillation is the most common heart rhythm condition in the world. Patients with this condition typically require blood-thinning medications such as the well-known warfarin. Pradaxa was the first alternative to warfarin approved in nearly 60 years. Problems were quick to follow. In November 2011, Boehringer Ingelheim confirmed at least 260 fatal bleeding events in patients taking Pradaxa.

Pradaxa side effects have prompted safety advisories in Japan and Australia and have led to labeling updates in Europe and the United States. The FDA recently required the German pharmaceutical manufacturer Boehringer Ingelheim to update its Pradaxa label after receiving a large number of adverse event reports from consumers. The January 2012 label change added minimal information regarding the dangers of bleeding events and the lack of a reversal agent for Pradaxa. The drug remains devoid of a “black box warning” or an FDA recall.

March 30, 2012 in Pradaxa | Permalink | Comments (0)