American Stroke Association Investigates Xarelto, Pradaxa Health Risks

To gauge the affect of new drugs on health and stroke risks, stroke experts have announced that they plan to review the safety of Pradaxa and similar blood thinners.

The American Stroke Association (ASA) will conduct this report, which will focus on Pradaxa, Xarelto, and other blood thinners (anticoagulants) that are recently replacing Coumadin (warfarin).

A high number of adverse event reports disclosing serious bleeding events and death in just the first year Pradaxa was on eth market has recently raised concerns in the media and in the medical community.

Karen Furie, director of stroke service and prevention at Massachusetts General Hospital and Dr. Larry Goldstein of the Duke Stroke Center will lead this investigation, known as “Novel Anticoagulants for the Prevention of Stroke in Atrial Fibrillation.”

Introduced in October 2010 by Boehringer Ingelheim, Pradaxa (dabigran) is a member of a new class of blood thinners known as “direct thrombin inhibitors”.  These drugs are designed to control an enzyme in the blood that causes blood to clot, and have been promoted as superior replacements to Coumadin to prevent strokes in atrial fibrillation patients.

The second drug released in this new class, Xarelto was introduced in November 2011 despite FDA staff recommendations against the drug.  An independent advisory committee passed a 9-to-1 vote to approve Xarelto for use as a stroke preventative in patients with atrial fibrillation.

Pradaxa was marketed as easier to use than Coumadin because it requires less monitoring.  For this reason, it became rapidly and widely used for patients with atrial fibrillation.  However, when patients have serious bleeding events with Coumadin, they can be rapidly counteracted with Vitamin K.  This is not the case with Pradaxa, and some experts have attributed this factor as the reason for a high number of Pradaxa deaths.

In a January 2012 report by the Institue of Safe Medication Practices, the agency reported that the FDA received more instances of Pradaxa hemorrhaging duirng the first quarter of 2011 than hemorrhaging reports linked to any other drug.  176 instances of Coumadin bleeding problems were reported, in stark contrast to the 505 instances of Pradaxa bleeding reported.

Contact a Pradaxa Lawyer

If you suffered internal bleeding after taking Pradaxa, you may wish to consider pursuing compensation for your damages in a dangerous drug lawsuit.  Contact an experienced pharmaceutical product liabilty attorney to learn more about your options in a free legal consultation.

March 7, 2012 | Tags: Dangerous Drugs, Pradaxa

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