Deaths Caused by Pradaxa

Taking Pradaxa, an anti-coagulant, was already known to carry the risk of excessive bleeding. A Boehringer spokesman indicated that the 260 reported deaths were in keeping with the results from a clinical trial that led to the drug’s approval.

Nonetheless, the comment seemed to conflict with the company’s November 2nd statement that called 50 reported deaths a “reasonable order of magnitude.”

Doctors prescribe Pradaxa in order to reduce the likelihood of debilitating or fatal strokes. The drug was ostensibly approved because the benefits outweighed the risks. Boehringer contends that those taking warfarin or Coumadin, which has been on the market for decades, have a 40% greater risk of fatal complications.

Warfarin, which is commonly known by the brand name Coumadin, has been used as a stroke preventer for decades. Many patients find taking warfarin to be a hassle because it interacts with vitamin K and requires frequent blood testing.
Boehringer maintains that among patients who have atrial fibrillation, the risk of fatal internal bleeding is higher with warfarin than with Pradaxa. The figure of warfarin being 40% more risky comes from the RE-LY study, the clinical trial that led to Pradaxa’s approval.

In response to Boehringer’s report, European health regulators stated that patients should have their kidneys checked prior to taking Pradaxa. Moderate kidney impairment might not have serious effects on drug metabolism, but Pradaxa should not be taken by people with very compromised kidneys. Japanese regulators contacted Boehringer as early as August 2011 regarding the potential for deadly bleeding.

A number of companies are vying to replace warfarin as the standard anti-clotting drug for patients with atrial fibrillation. The rival anti-coagulants include Eliquis from Bristol-Myers Squibb and Pfizer, Lixiana from Daiichi Sankyo, and Xarelto from Bayer and Johnson & Johnson. They’re competing for a market that’s valued at approximately $10 billion to $20 billion per year. In their rush to control the market and reap the financial rewards, some accuse these companies of cutting corners and producing drugs with seriously dangerous side effects.

If you have taken Pradaxa and suffered from internal bleeding, you may be entitled to collect significant financial compensation. To find out if you have a case, contact our Team of Lawyers for a free no obligation consultation by completing the form on this page or calling 1.800.862.1260.
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