By Amanda Antell  |  March 18, 2014

Category: Legal News

Pradaxa lawsuitPharmaceutical giants Boehringer Ingelheim and Johnson & Johnson are disputing a recent drug assessment comparing their anticoagulant drugs to Pfizer’s new blood thinner, Eliquis, saying that Eliquis is too new on the market and its risk level cannot be accurately assessed.

In a bid to break into the anticoagulant market, Pfizer manufactured a new drug called Eliquis, which is prescribed to patients who are at risk for stroke or for those with atrial fibrillation.

Pfizer claims that Eliquis is not subject to the same risk of uncontrollable internal bleeding, such as with Pradaxa and Xarelto. The other two drug companies argue that Eliquis is too new, and that there are not enough prescriptions to make such a statement.

Healthcare information company AdverseEvents published a report last month, which examined the comparative safety of different blood thinners including: Pradaxa, Xarelto and Eliquis. According to the findings, Eliquis actually appeared to be safer compared to the rest of the drugs. Experts involved in the study believe it is because Eliquis is part of the Xa inhibitor family.

The results of the study were based on an analysis of injury reports from the FDA. Statistics were gathered from the number of injuries reported in relation to each drug, as well as the severity of each incident.

However, Boehringer and Johnson & Johnson and Bayer, the manufacturers of Pradaxa and Xarelto respectively, stated that the findings of the study were unfair and inaccurate, because injury reports are often unspecific, unreliable, and are submitted based on the patient’s discretion.Therefore, the results cannot accurately depict the amount of injury rates of these drugs.

Pradaxa and Xarelto have been approved by the U.S. Food and Drug Administration to treat various conditions. Since released, each blood thinner has garnered millions of prescriptions across the United States, and have remained immensely popular despite recent revelations.

In contrast, Eliquis is approved only for a single use and has only conquered one portion of the blood-thinner market, with only 435,000 prescriptions so far. Johnson & Johnson and Boehringer point out that because the drug is so new, and because there aren’t many prescriptions, that it would be natural for the injury reports numbers to be smaller.

As of now, all blood thinners have been linked to adverse effect reports regarding uncontrollable bleeding. Warfarin, the first approved anticoagulant, is the only blood thinner with a reversal agent to stop this event. There are no approved reversal agents for the new generation anticoagulants.

Overview of Pradaxa and Xarelto Complications

Pradaxa was first approved by the FDA on October 19, 2010, and is the second drug in the pharmaceutical history of the United States,to be approved as an anticoagulant, after Warfarin. It was approved to prevent stroke and systemic embolism for patients who have non-valvular atrial fibrillation. Its anticoagulant function worked too well, as reports of death and uncontrollable bleeding flooded the FDA and Boehringer’s office.

>>Pradaxa Bleeding Lawsuits

In facing similar problems, Xarelto also soon fell under the same accusations soon after its release, after it was approved by the FDA in 2011. Xarelto became the third blood thinner approved in the United States, approved for the same purposes as its predecessors, Warfarin and Pradaxa. Unfortunately, it was soon discovered that Xarelto carried the same risks of uncontrollable bleeding, and similar to Pradaxa, the drug had no reversal agent.

The injuries indicated in Pradaxa and Xarelto adverse effect reports include but are not limited to:

  • Death
  • Intestinal bleeding
  • Rectal bleeding
  • Brain hemorrhaging

Pradaxa Litigation Movement

Currently, Boehringer Ingelheim is facing more than 2,000 Pradaxa lawsuits, each alleging that the company failed to warn them that there was no reversal agent in the event of uncontrollable bleeding.  Last month, the first Xarelto lawsuit was filed against Johnson & Johnson, with similar allegations.

File a Pradaxa Lawsuit Today

If you believe that you or a loved one have been the victim of a Pradaxa internal bleeding injury, you have legal options. Please visit the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned Pradaxa lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees.  The Pradaxa attorneys working this investigation do not get paid until you do.

 

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