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EMA Calls For Stronger Pradaxa Warnings

Last Friday, the European Medicines Agency determined that clearer guidance is needed for both doctors and patients about how to use Boehringer Ingelheim’s controversial anticoagulant Pradaxa.

May 30, 2012 – Last Friday, the European Medicines Agency (EMA) determined that clearer guidance is needed for both doctors and patients about how to use Boehringer Ingelheim’s controversial anticoagulant Pradaxa (generic: dabigatran). Since it was first approved by the U.S. Food & Drug Administration (FDA) in October 2010, Pradaxa has been increasingly linked to uncontrollable hemorrhaging, bleeding events, and death. 

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?

In a statement issued on May 25th, the EMA indicated that while it believes Pradaxa does not yet need to be recalled, it should be prescribed with stronger warnings, including more specific guidance on when it should not be used and how to manage bleeding problems that do occur.

Although Boehringer markets Pradaxa as superior to Coumadin 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.

Following an assessment of all available data, the EMA’s Committee for Medicinal Products for Human Use (CHMP) ultimately determined that Pradaxa should remain on the market, but that advice given to doctors and patients should be updated and strengthened to give clearer guidance on the best use of the drug. Moving forward, new information will be provided to prescribing doctors regarding when Pradaxa should not be used, as well as stronger warnings to seek medical attention if patients fall and injure themselves during the course of treatment.

Here at home in the United States, Boehringer faces a slew of Pradaxa lawsuits filed on behalf of individuals who have allegedly been injured by the drug’s side effects. The complaints allege that the company failed to warn the public about the potentially life-threatening bleeding risks associated with Pradaxa. A Pradaxa safety investigation is currently being conducted by the FDA.

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.

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