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Study Finds Bleeding Risk With Pradaxa Higher Than With Warfarin

5 February 2015No Comments

PradaxaThe findings of an important new study indicate that patients taking the newer anticoagulant drug Pradaxa may be more likely to experience severe bleeding problems than those taking the older blood thinner warfarin. The research comes amid increasing concerns about the potential side effects of Pradaxa, Xarelto and other new-generation anticoagulants, which drug makers say require less patient monitoring during treatment, but which may actually expose patients to an increased risk of potentially life-threatening side effects. If you took Pradaxa in the past, and you have since experienced serious bleeding problems, consult our reputable Pradaxa attorneys at Bandas Law Firm today to discuss your legal options.

Potential Side Effects of Pradaxa

Pradaxa (dabigatran) was the first of a new class of anticoagulant medications introduced in the United States, and was approved by the FDA in late 2010, for the prevention of strokes in patients with a heart condition called atrial fibrillation. Pradaxa quickly became a blockbuster drug, and its success led to the introduction of other new-generation blood thinners like Xarelto and Eliquis. However, in a study published in JAMA Internal Medicine in January, researchers from the United States and Spain found that side effects of Pradaxa were associated with a more than 50% increased risk of major bleeding events, and an 85% increased risk of gastrointestinal bleeding, compared to warfarin, which has been on the market for decades.

Doctors Unable to Control Pradaxa Bleeding Events

New-generation blood thinners like Pradaxa have been marketed by their manufacturing companies as superior alternatives to warfarin, with claims suggesting that Pradaxa is just as effective as warfarin, and is easier to use because it requires less patient monitoring during treatment. However, a growing body of research has identified the use of Pradaxa, Xarelto and other new-generation anticoagulants as a potential risk factor for severe bleeding problems. And because there is currently no approved antidote to reverse the blood thinning effects of the newer medications, many doctors have reported incidents of severe and uncontrollable bleeding complications among Pradaxa users.

Bleeding, GI Problems from Pradaxa Use

In this latest study, researchers from the University of Pittsburgh and La Paz University Hospital in Spain examined pharmacy and medical claims from 2010 to 2011, involving patients recently diagnosed with atrial fibrillation. They found data on 1,302 patients taking Pradaxa, and 8,102 patients taking warfarin, and found that Pradaxa was associated with a 30% higher overall bleeding rate when compared to warfarin. More specifically, the risk of major bleeding events with Pradaxa was 58% higher, and the risk of gastrointestinal bleeding complications with Pradaxa was 85% higher. As a result of their findings, the researchers noted that “[Pradaxa] should be prescribed with caution, especially among high-risk patients.”

Our Experienced Pradaxa Lawyers Can Help

More than 4,000 lawsuits were filed against Boehringer Ingelheim as a result of alleged Pradaxa bleeding complications, and the drug maker recently agreed to pay $650 million to settle claims brought on behalf of former Pradaxa users who suffered injuries from uncontrollable bleeds. Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals unit also face a growing number of product liability lawsuits filed over bleeding complications from its Xarelto blood thinner, all of which involve similar allegations to those raised in the Pradaxa litigation. If you believe you have been adversely affected by Pradaxa or another potentially dangerous pharmaceutical drug, contact our product liability lawyers at Bandas Law Firm today for qualified legal help.

Source: http://archinte.jamanetwork.com/article.aspx?articleid=1921753

Posted Under: Drug Litigation, Homepage Featured