Pradaxa, a prescription blood thinner, has been on the market since 2010. It was the first drug to be approved for anticoagulant treatment purposes since warfarin in the 1950s.

However, patients began reporting uncontrollable internal bleeding injuries soon after its release, with many complaining the Pradaxa blood thinner was unreasonably dangerous for patients.

The FDA received 307 injury reports within the first three months of Pradaxa being sold on the market and 260 alleged deaths within the first year. In December 2011, the FDA issued a public warning about uncontrollable internal bleeding in conjunction with the Pradaxa blood thinner. The agency issued its warning after post-marketing reports indicated serious problems, spurring the FDA to evaluate whether or not the Pradaxa blood thinner presented unreasonably dangerous risks to patients.

In addition to the FDA warning, the Institute for Safe Medication Practices (ISMP) published a report describing the number of Pradaxa injury reports submitted to the FDA.

Overall, patients taking the Pradaxa blood thinner or other anticoagulants should be wary for signs of internal bleeding including:

• Unusual Bruising or Bleeding
• Pink or Brown Urine
• Red or Black Tarry Stool
• Coughing or Blood
• Vomit that looks like Coffee Grounds
• Headaches
• Fatigue
• Frequent Nose Bleeds
• Bleeding from Gums
• Weakness and Swelling in Arms and Legs

Research indicates patients may be at higher risk if they are elderly or have kidney problems, which can result in dangerous circulation levels. Patients may also face greater risks if they are taking other medications linked to internal bleeding such as certain pain medications or other anticoagulants.

Overview of Pradaxa Blood Thinner

Like other anticoagulants, Pradaxa blood thinner works by inhibiting the clotting mechanism in the body. This makes Pradaxa an ideal choice for patients suffering from atrial fibrillation or who have a high risk for stroke, as the anticoagulant mechanism helps prevent the onset of a blood clot attack.

However, this mechanism prevents the body from initiating self-recovery methods in cases of internal bleeding, which can lead to potentially fatal consequences.

Until the release of Praxbind in 2015, patients prescribed the Pradaxa blood thinner who experienced uncontrollable internal bleeding injuries often required emergency surgery to correct the issue. Even though warfarin had an approved reversal agent, the newer blood thinner quickly became more popular due to its convenient single dose prescription feature. While all anticoagulants carry some degree of internal bleeding, for many years only warfarin had an approved reversal agent available to patients.

Numerous patients have filed Pradaxa lawsuits against manufacturer Boehringer Ingelheim for allegedly knowing about the risk of uncontrollable bleeding and not disclosing it to the public. A Pradaxa internal bleeding class action investigation is currently underway, looking into claims from patients who allegedly suffering uncontrollable internal bleeding. These claimants allege various claims for negligence and failure to warn, stating the company either knew or should have known about the risks.