Pradaxa hemorrhage is a considerable risk when being prescribed the new generation anticoagulant. While it’s a popular treatment mechanism to reduce the risk of stroke associated with atrial fibrillation, Pradaxa and other new generation anticoagulants have been reportedly causing uncontrollable internal bleeding complications.

Approved by the FDA in 2010, Pradaxa was manufactured and released by Boehringer Ingelheim as the first medication to be released for anticoagulant purposes since warfarin’s release in the 1950s. The release of Pradaxa inspired other pharmaceutical companies to break into the lucrative anticoagulant market, with Xarelto and Eliquis released in 2011 and 2012 respectively.

However, it was not long after the drug’s release that Pradaxa hemorrhage became a prevalent concern to the patient population and medical community. Even though Pradaxa and other new generation anticoagulants are marketed to be more effective and convenient than warfarin, these newer anticoagulants do not have a widely available bleeding antidote.

Even with the recent release of Praxbind, Boehringer Ingelheim’s Pradaxa antidote, patients can only receive the reversal agent in hospitals. In contrast, warfarin patients can implement vitamin K to stop any internal bleeding incidents.

Overview of Pradaxa Hemorrhage Complications

The cause of Pradaxa hemorrhage stems from the treatment mechanism of the anticoagulant, which is meant to prevent blood from clotting. By inhibiting the body’s clotting mechanism, Pradaxa inhibits the body’s ability to recover from minor internal bleeding injuries.

Pradaxa hemorrhage can be potentially fatal, and has reportedly resulted in 260 deaths worldwide. According to the RE-LY clinical safety study, a significant portion of Pradaxa patients may experience internal bleeding with the risk especially prevalent in the gastrointestinal tract.

According to the researchers of the RE-LY study, the rates of Pradaxa internal bleeding injuries were as follows:

• 17.4% of Pradaxa patients experience bleeding problems require emergency intervention
• 16.4% of Pradaxa patients experience bleeding
• 3.3% of Pradaxa patients experience bleeding
• 1.5% of Pradaxa patients experience life-threatening bleeding
• 0.3% of Pradaxa patients experience life-threatening brain bleeding

In addition, the RE-LY researchers warn that patients may carry a 6% risk of Pradaxa hemorrhage per every year of use.

In December 2011, the FDA had issued a public warning regarding potential Pradaxa hemorrhage. The agency stated that they were evaluating the potential risks the medication may carry, and if the medication may be unreasonably dangerous. Patients should be wary for any signs of Pradaxa hemorrhage including:

• Abdominal Pain
• Blood in Stool or Urine
• Vomiting Blood
• Changes in Skin Color

Even though Pradaxa hemorrhage is a potentially fatal result for patients, Boehringer Ingelheim allegedly failed to disclose this information to the public, according to Pradaxa lawsuits against the drug’s manufacturer. Even though Praxbind helps prevent future fatalities, it does not help patients who have already experienced Pradaxa hemorrhage.

Patients who have suffered Pradaxa hemorrhage may be able to file legal action. Potential claimants should contact a knowledgeable lawyer to determine eligibility for a Pradaxa lawsuit.