Serious Pradaxa bleeding is a prevalent concern in the United States, with the patient population and medical community growing increasingly wary of the new generation anticoagulant.

Across the country, patients continue to report serious Pradaxa bleeding incidents that could have been fatal if not for emergency intervention.

Until 2015, there was no widely available reversal agent for Pradaxa and patients often had to be hospitalized during serious Pradaxa bleeding. With the release of Praxbind, patients now have a reversal agent ready to be utilized at awaiting hospitals if needed.

Even with Praxbind available, patients should still be wary about uncontrollable internal bleeding events.

Pradaxa was approved by the FDA in 2010 to be a treatment option for patients suffering from atrial fibrillation or who are at higher risk for stroke. Anticoagulants work by inhibiting the body’s clotting mechanism which increases circulation efficiency and prevents blood clots from forming. However, this function also impairs the body’s natural mechanism for getting bleeding under control. This medication has reportedly resulted in numerous cases of serious Pradaxa bleeding, resulting in some deaths and many emergency room cases.

Overview of Serious Pradaxa Bleeding

Before the release of Pradaxa in 2010, warfarin had been the top choice of blood thinners for patients at high risk for blood clot attacks. While an effective anticoagulant, warfarin patients had to frequently see their physicians for dose adjustments. Pradaxa and other new generation anticoagulants carried a single dose prescription feature, which made them very popular for patients.

However, this convenience came with less medical monitoring, which critics say may have increased the risk of serious Pradaxa bleeding incidents. It is important to note that warfarin has always had a reversal agent that could be utilized to resolve potentially fatal internal bleeding incidents.

Pradaxa did not have such a reversal agent until five years after its release date, which put numerous patients at risk for serious Pradaxa bleeding incidents including:

• Kidney Bleeding
• Gastrointestinal Bleeding
• Heart Attack
• Stroke
• Brain Hemorrhage
• Death

According to the FDA, there were 307 injury reports indicating Pradaxa internal bleeding problems in the first three months of the drug was released into the market. Within the first year, there had been 260 deaths allegedly caused by serious Pradaxa bleeding injuries.

These injury reports eventually spurred the FDA to issue a public warning in December 2011, to notify patients and doctors that Pradaxa could increase uncontrollable internal bleeding risks. Pradaxa patients should be wary of any signs or symptoms of internal bleeding including:

• Frequent Nose Bleeds
• Gums Bleeding
• Oddly Colored Urine
• Red or Black Stools
• Coughing up Blood
• Vomiting up Blood

Patients should seek medical attention immediately if they are experiencing these symptoms, as internal bleeding can quickly become fatal. Even though serious Pradaxa bleeding was a significant risk to patients, manufacturer Boehringer Ingelheim allegedly failed to notify the public. Boehringer Ingelheim is currently facing legal action for serious Pradaxa bleeding injuries, with claimants alleging the company either knew or should have known about their drug’s allegedly dangerous nature.