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Pradaxa Side Effects Top 2011 FDA Adverse Event Reports

Pradaxa was linked to more severe complications in 2011 than any other drug monitored, according to a new report submitted to the FDA. 

Boehringer Ingelheim’s controversial new blood thinner Pradaxa was linked to more severe complications in 2011 than any other drug monitored, according to a new report submitted to the U.S. Food & Drug Administration (FDA). 

Free Pradaxa Lawsuit Evaluation: If you or a loved one has been injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

Last year, the FDA received at least 3,781 adverse event reports (AERS) involving serious injuries associated with the use of Pradaxa (generic: dabigatran), which included:

  • 542 patient deaths
  • 2,367 reports of hemorrhage
  • 291 cases of acute renal failure
  • 644 strokes

The sheer number of complications linked to Pradaxa surpassed all other drugs monitored by the Institute for Safe Medication Practices (ISMP).

Although Boehringer markets Pradaxa as superior to Coumadin (generic: warfarin) because it supposedly requires less patient monitoring, it does not have a reversal agent that can be used when internal bleeding events occur. When bleeding occurs with Coumadin, a simple dose of vitamin K can be used to counteract the problem. Warfarin, which was approved by the FDA in 1954 and has been a staple of anticoagulant treatment ever since, was associated with 1,106 AERS in 2011, including 72 deaths.

The FDA is currently in the process of conducting a safety investigation into the bleeding events associated with Pradaxa. The results of the study will determine what regulations should be taken to protect the public from the risk of Pradaxa side effects.

Do I Have a Pradaxa Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

Free Confidential Case Evaluation

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