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According to a safety communication issued by the FDA, Pradaxa (dabigatran) has been reported as causing internal bleeding.

The drug – which is used to treat atrial fibrillation – is a blood thinning medication. It is part of a class of drugs known as “direct thrombin inhibitors.” These types of drugs work by inhibiting the enzyme which causes blood clotting that often lead to stroke and death. However, the drug may be thinning blood too much as the medication is excreted through the kidneys hindering the kidneys performance, leading to an abnormally high amount of the drug in the system, thus causing internal bleeding.

Potential Pradaxa internal bleeding may include blood in the urine, pink or brown stools, vomiting of blood, bruises with unknown causes, and more. Seek medical attention immediately.

No recall has been issued at the time of this writing but the FDA is in the process of investigating these claims of internal bleeding which may have been caused by Pradaxa. The FDA approved Pradaxa in the U.S. in October of 2010. Shortly after its release, numerous reports of internal bleeding and other adverse side effects of Pradaxa were reported.

These adverse effects may include:

  • Gastrointestinal bleeding (GI)
  • Heart attack
  • Brain hemorrhaging
  • Kidney bleeding
  • Death

The FDA recommends that you contact your healthcare professional today if you have suffered any of these side effects.

If you have suffered internal bleeding or other adverse effects such as those listed above, you may be eligible to file a Pradaxa lawsuit. The attorneys at the Spangenberg Law Firm are currently reviewing cases and will be happy to help. Contact our experienced attorneys today by calling (877-696-3303).

For additional updates, see: Pradaxa Information.


  1. Gravatar for Concerned

    What about the risk of heart attacks with Pradaxa? I see internal bleeding on the website you list, but not a lot about heart attacks . . .

  2. Gravatar for William Eadie

    @concerned, yes, heart attack risks are increased according to some recent research. I will be posting a follow-up post soon; please check back!

  3. Gravatar for Anonymous

    I found some great information regarding the Pradaxa internal bleeding lawsuits on your website. Thanks for the updated info.

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