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Shezad Malik MD JD
Shezad Malik MD JD
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First Pradaxa Side Effects Lawsuits Filed

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The first three federal Pradaxa injury and death cases in the United States were recently filed.

The first three landmark federal court Pradaxa lawsuits filed this week include: Lege et al v. Boehringer Ingelheim Pharmaceuticals Inc et al, Cause No. 6:12-cv-00572, in the U.S. District Court for the Western District of Louisiana; Bivens et al v. Boehringer Ingelheim Pharmaceuticals, Inc et al, Cause No. 3:12-cv-00103, in the U.S. District Court for the Eastern District of Tennessee, Northern Division; and Hawkins et al v. Boehringer Ingelheim Pharmaceuticals Inc et al, Cause No. 6:12-cv-45, in the U.S. District Court for the Eastern District of Kentucky, London Division.

There is an ongoing U.S. Food and Drug Administration (FDA) investigation into Pradaxa and its potentially deadly side effects. The FDA is now investigating post-marketing reports of serious bleeding events and deaths in patients taking Pradaxa (dabigatran etexilate).

Pradaxa History

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 atrial fibrillation require blood-thinning medications like warfarin. Pradaxa was the first alternative to warfarin approved in nearly 60 years.

Pradaxa Side Effects and the FDA

In November 2011, Boehringer Ingelheim confirmed at least 260 fatal bleeding events in patients taking Pradaxa.

Pradaxa side effects have led safety regulators in Japan and Australia to investigate and have led to labeling updates in Europe and the United States.

New FDA Warning Label

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 does not have a “black box warning” or an FDA recall.

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