Internal Bleeding From Side Effects of Pradaxa

Pradaxa (generic dabigatran) is a relatively new blood thinner that was introduced as a replacement for warfarin in the prevention of strokes among individuals suffering from atrial fibrillation. However, the potential risk of Pradaxa bleeding side effects caused serious concern surrounding the drug shortly after it was introduced.

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Symptoms of Pradaxa internal bleeding may include:

  • Unusual Bruising or Bleeding
  • Pink or Brown Urine (which may be a sign of Blood in the Urine)
  • Red or Black Tarry Stool (which may be a sign of Blood in the Stool)
  • Coughing up Blood (which may include vomiting that resembles coffee grounds)
  • Headaches, Dizziness or Lethargy
  • Bleeding from the Gums or Frequent Nose Bleeds
  • Weakness and Swelling of the Arms, Hands, Feet, Ankles or Lower Legs

As a result of the drug makers failure to adequately warning about the bleeding risks, Pradaxa lawsuits are being reviewed by the lawyers at Saiontz & Kirk, P.A. for individuals throughout the United States.

Millions have already been received in Pradaxa bleeding settlements by former users and family members of individuals who have died. To review whether you or a loved one may be entitled to financial compensation, request a free consultation and case evaluation.


Pradaxa is part of a class of drugs known as “direct thrombin inhibitors”, which inhibit the enzyme in the blood that causes blood to clot.

While the medication is promoted for prevention of strokes caused by blood clots among individuals with atrial fibrillation, Pradaxa side effects may make it nearly impossible for blood to clot in times of need.

Research has suggests that there are serious concerns about gastrointestinal bleeding with Pradaxa, finding:

  • 16.6% of all users may experience some Pradaxa internal bleeding
  • 3.3% may experience serious bleeding on Pradaxa
  • 1.5% may experience life-threatening Pradaxa bleeding effects
  • 0.3% may experience brain hemorrhage on Pradaxa

Elderly individuals and those with kidney problems may face a greater risk of Pradaxa bleeding problems, as the drug is excreted through the kidneys. When the kidneys are unable to process the drug out of the body, it may result in abnormally high levels in circulation, causing an even greater risk.

The risk of GI bleeds with Pradaxa may also be higher for users who are taking other medications linked to an internal bleeding risk, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) or other blood thinners.


The FDA approved Pradaxa in October 2010, and adverse event reports immediately surfaced that suggest the Pradaxa bleeding side effects may be more significant than first believed. While there has been no indication that a Pradaxa recall will be issued, regulators in the United States and other countries are closely monitoring this new prescription medication.

According to a report (PDF) by the Institute for Safe Medication Practices, more than 307 adverse event reports involving Pradaxa were filed with the FDA during the first three months the drug was on the market. This exceeds 98.7% of the other drugs monitored by the organization and is 50% more than were associated with warfarin, an older and cheaper blood thinner that Pradaxa was designed to replace.

In August 2011, the Japanese health ministry sent a letter to Boehringer Ingleheim requesting that the drugmaker warn doctors about the risk of fatal bleeding with Pradaxa, indicating that at least 81 elderly patients in the country experienced hemorrhaging and at least 14 deaths were linked to Pradaxa. Japanese officials suggested that patients over 70 may require lower doses.

In October 2011, a letter (PDF) published in the medical journal Therapeutics Initiative questioned the approval of Pradaxa and indicated that the trials used to establish that it was safe and effect were fundamentally flawed. While the clinical trials, known as RE-LY, used a double blind method of comparing two doses of Pradaxa, a non-blinded comparison was used between Pradaxa and warfarin, allowing bias and errors to potentially impact the results.

In December 2011, the FDA issued a drug safety communication to inform the public and medical community that the potential Pradaxa internal bleeding risk was being reviewed as a result of post-marketing reports of problems. While the agency indicated that bleeding is a known risk with all blood thinners, the agency is examining whether there is anything abnormal about the side effects of Pradaxa that could be an unreasonable risk to consumers.


Millions in Pradaxa settlements have already been paid by the drug maker to resolve lawsuits brought by individuals who alleged that inadequate warnings were provided for consumers and the medical community.

Due to the continued failure to provide sufficient warnings about the potential side effects, the Pradaxa attorneys at Saiontz & Kirk, P.A. are continuing to review potential cases for individuals who have suffered a serious injury or death from internal bleeding or hemorrhages on Pradaxa.

In addition, potential Xarelto bleeding lawsuits are also being reviewed for individuals who suffered bleeding injuries after use of this similar anticoagulant.

Saiontz & Kirk, P.A. investigates and pursues all Pradaxa side effect lawsuits under a contingency fee, which means that there are no attorney fees until a recovery is secured for injuries or wrongful death.