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Pradaxa Linked to Increased Risk of GI Bleeding Compared to Warfarin: FDA

A new study has found that Pradaxa may be associated with an increased risk of major gastrointestinal bleeding compared to warfarin.

A new study has found that Pradaxa, a blood-thinning drug made by Boehringer Ingelheim, may be associated with an increased risk of major gastrointestinal bleeding compared to warfarin, an anticoagulant that’s been in use for more than a half-century in the United States. First approved in October 2010, Pradaxa is marketed as an alternative to warfarin for stroke prevention in patients with atrial fibrillation (A-fib).

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?

On May 13, 2014, the FDA issued a Drug Safety Communication warning about a new study that compared Pradaxa (generic: dabigatran) to Coumadin (generic: warfarin). The study, which involved over 134,000 Medicare patients aged 65 years or older, looked at the risk of stroke, brain bleeds, gastrointestinal (GI) bleeding, myocardial infarction (MI) and death associated with the anticoagulants. The researchers determined that Pradaxa was linked to a lower risk of these complications compared to warfarin; however, Pradaxa was found to cause more significant GI bleeding events.

The new study was performed on a much larger and older patient population than those used in earlier data reviews on Pradaxa, and used more sophisticated methods to reach the findings. The researchers’ conclusions, except with regard to myocardial infarction, are consistent with the clinical trial results that were the basis of Pradaxa’s initial approval in 2010. As a result of the new study, FDA still considers the benefits of Pradaxa to outweigh the risks, and no changes have been made to the drug’s labeling.

FDA Recommendation on Pradaxa

FDA is advising patients not to stop taking Pradaxa without talking to their doctor first.
Discontinuing use of anticoagulants may increase the risk of stroke and lead to permanent disability and even death. Doctors who prescribe Pradaxa should continue to follow the recommended dosing instructions on the drug’s labeling.

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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