Pradaxa and Internal Bleeding - Consumer Justice Foundation

Pradaxa and Internal Bleeding

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Internal Bleeding Symptoms

According to side effect information about the new blood thinner Pradaxa, patients who take the anticoagulant to reduce their risk of blood clots and stroke could be putting themselves at risk of potentially fatal internal bleeding or hemorrhaging. Common symptoms of internal bleeding potentially linked to Pradaxa include:

  • Lethargy
  • Unusual bleeding or bruising/hemorrhaging
  • Coughing up blood
  • Pink or brown urine
  • Frequent nosebleeds
  • Dizziness or weakness
  • Joint pain or swelling

Pradaxa Internal Bleeding Prognosis

According to the FDA, a large clinical trial comparing Warfarin and Pradaxa side effects indicated that major bleeding events occurred at similar rates with the two drugs. However, despite the fact that bleeding is a well-known side effect of other anticoagulants, like Warfarin, internal bleeding in Warfarin patients can be treated with vitamin K. On the other hand, there is currently no antidote for internal bleeding side effects associated with Pradaxa and other direct thrombin inhibitors. In light of this internal bleeding side effect risk, the FDA has included a warning in the anticoagulant’s medication guide alerting patients and physicians about the potential for Pradaxa to cause serious bleeding and possibly death.

Pradaxa Side Effect Studies and FDA Warnings

In December 2011, the FDA issued a safety announcement warning patients and physicians about the potential for Pradaxa use to cause serious bleeding side effects. The agency indicated that it would be evaluating post-marketing reports of severe bleeding events in patients taking Pradaxa. This FDA warning came on the heels of Pradaxa side effect warnings in other countries, including Japan and New Zealand, which raised concerns about the possible connection between Pradaxa and potentially life-threatening internal bleeding or hemorrhaging.

In August 2011, Japanese regulators ordered Pradaxa (sold in Japan as Prazaxa) maker, Boehringer Ingelheim, to issue a warning to the public regarding potentially fatal bleeding side effects associated with the medication. This request was issued after 81 of the almost 64,000 mainly elderly patients taking Pradaxa in Japan suffered heavy bleeding, leading to five deaths. In September 2011, New Zealand health officials launched a Pradaxa investigation after as many as five elderly patients taking Pradaxa reportedly died due to internal bleeding or hemorrhaging. Another 36 Pradaxa patients reportedly suffered from bouts of serious internal bleeding.

Contact a Pradaxa Attorney for Help

While the FDA conducts an investigation into the unusually large number of serious bleeding side effects linked to Pradaxa, Japan and Australia have already issued a safety warning regarding potential Pradaxa side effects. If you or a loved one has suffered from a major side effect, and you believe Pradaxa to be the cause, contact a qualified Pradaxa attorney to discuss your legal options. You may have grounds to file a Pradaxa lawsuit against Boehringer Ingelheim, in order to seek financial compensation for your injuries, the medical cost of treating your injuries, and the pain and suffering endured by you and your family. You are not at fault for any side effects caused by a dangerous pharmaceutical drug. With the help of an experienced Pradaxa lawyer, you can protect your legal rights and bring public attention to the potentially harmful nature of the blood thinner.

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