Internal bleeding and Pradaxa have had a concerning link for the past several years, with patients still at risk for a potentially fatal internal bleeding event.

Boehringer Ingelheim had recently settled numerous Pradaxa injury claims, which were filed by patients alleging they were not warned against uncontrollable internal bleeding and Pradaxa use.

Boehringer Ingelheim paid $650 million to settle 4,000 Pradaxa bleeding lawsuits in 2014, but patients will most likely continue to file claims alleging internal bleeding and Pradaxa for some time. This bleeding is a risk because Pradaxa works by inhibiting the body’s clotting mechanism to increase the efficiency of blood flow, which eases the circulation.

However, this also inhibits the body’s recovery process in cases of internal bleeding, which can become potentially fatal. While Pradaxa does have an approved reversal agent in the form of Praxbind, patients still need to seek emergency treatment in cases of internal bleeding.

New Generation Anticoagulants

Pradaxa is a new generation anticoagulant that entered the market in 2010, which is often prescribed to patients suffering from atrial fibrillation and who are at high risk for stroke.

It is important to note that Pradaxa was the first medication to be approved for anticoagulant treatment since warfarin in the 1950s. Pradaxa opened the gateway for other new generation blood thinners, Xarelto and Eliquis.

When Pradaxa was first released it was marketed to be more efficient and convenient that warfarin, with Boehringer Ingelheim emphasizing the fact that it can be prescribed in a single dose. However, while Pradaxa did not require frequent doctor appointments for dose adjustments like warfarin, this medication did not have approved bleeding antidote for the first five years it had been on the market.

Overview of Pradaxa and Internal Bleeding

The correlation between Pradaxa and internal bleeding became apparent soon after the drug’s release, with the FDA receiving 307 injury reports within the first three months of it entering the market. Furthermore, the FDA had received over 260 death reports worldwide alleging these fatalities were caused by Pradaxa and internal bleeding.

The FDA released an official warning regarding Pradaxa and internal bleeding in December 2011, which stated patients may be at risk for uncontrollable internal bleeding.

While the FDA stated that uncontrollable internal bleeding was a “well recognized risk” associated with anticoagulant therapy, it stated that further research was needed to determine if Pradaxa presented an unreasonable risk to patients.

According to the cornerstone RE-LY safety study, which compared Pradaxa and warfarin bleeding complications, researches noted the following statistics:

• 17.4% of Pradaxa patients needed emergency surgery after serious internal bleeding
• 16.4% of Pradaxa patients experienced internal bleeding
• 3.3% of Pradaxa patients experienced serious internal bleeding
• 1.5% of Pradaxa patients experienced life threatening bleeding
• 0.3% of Pradaxa patients experienced serious brain bleeding

While there was concern over the accuracy of this study, as expressed by doctors in New Zealand, the study left the United States medical community highly concerned over the long term complications of Pradaxa and internal bleeding.

Overall, Pradaxa patients are advised to be vigilant against any symptoms of internal bleeding and to seek medical help immediately if they experience these side effects:

• Vomiting Blood
• Coughing up Blood
• Bleeding Gums
• Frequent Nosebleeds
• Red or Black Stool
• Coughing up Blood
• Pink or Brown Urine
• Unusual or Unexplained Bruising