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Pradaxa Complaints Increase Despite FDA Approval

By Kevin M. Hart on December 5, 2012
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Pradaxa (dabigatran etexilate mesylate) is a blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in October 2010, to prevent strokes among patients with atrial fibrillation (irregular heartbeat).

In the last quarter of 2010 alone, the FDA received over 300 complaints about the side effects of Pradaxa. In November 2011, Boehringer, the German-based manufacturer or Pradaxa, admitted to knowledge of at least 260 cases of fatal bleeding. In the U.S., Boehringer has offices in Connecticut, Iowa, Missouri, Ohio and Virginia. The FDA issued an updated safety communication in December 2011 to warn patients and health care providers about the potential link between the drug and the risk of bleeding. Despite the increased warnings, the FDA opined that the benefits still outweighed the risk and advised patients to seek medical advice before discontinuing its use.

If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.

Photo of Kevin M. Hart Kevin M. Hart

Kevin M. Hart is an expert Civil Trial Attorney as certified by the Supreme Court of New Jersey. Mr. Hart is also a member of the firm’s Litigation, Corporate Investigations & White Collar, Shareholder & Partner Disputes, Insurance Coverage & Liability, and Mass…

Kevin M. Hart is an expert Civil Trial Attorney as certified by the Supreme Court of New Jersey. Mr. Hart is also a member of the firm’s Litigation, Corporate Investigations & White Collar, Shareholder & Partner Disputes, Insurance Coverage & Liability, and Mass Tort practices.

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Mass Torts Law Blog
  • Organization:
    Stark & Stark

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