Pradaxa bleeding risk has been a significant concern to the medical community and patient population for years, even after it received an approved reversal agent in 2015.

Even though the availability of Praxbind helps lower the chances of internal bleeding incidents being fatal, patients should still be wary of the possibility of a Pradaxa bleeding risk.

Pradaxa was the first medication to be released for anticoagulant purposes since the release of warfarin in the 1960s. Concerns about Pradaxa bleeding risk have been prevalent since the drug’s release in 2010.

Pradaxa Risks

The release of Pradaxa was considered a major breakthrough and was very lucrative for manufacturer Boehringer Ingelheim, but the severity of the Pradaxa bleeding risk was discovered not long after.

In just the first three months the drug was on the market, the FDA had received 307 injury reports of uncontrollable Pradaxa gastrointestinal and other internal bleeding injuries.

Furthermore, there had been over 260 deaths linked to Pradaxa internal bleeding complications including gastrointestinal bleeding, hemorrhage, and stroke during its first year on the market.

The Pradaxa bleeding risk spurred the FDA to issue a public warning in December 2011, informing patients and physicians the anticoagulant could cause potentially fatal internal bleeding in patients. Even with the approval of Praxbind, the Pradaxa bleeding antidote, and a public FDA warning, the Pradaxa bleeding risk still remains a prevalent concern.

Since its approval, Pradaxa has been linked to over 1,000 deaths and numerous serious internal bleeding injuries. Pradaxa patients should be vigilant for any signs of internal bleeding including:

• Bleeding Gums
• Frequent Nosebleeds
• Black or Tarry Stools
• Discolored Urination
• Coughing up Blood
• Vomiting Blood

Patients who experience these complications should seek medical help immediately.

Overview of Pradaxa and Anticoagulants

Pradaxa and other anticoagulants work by shutting down the body’s clotting mechanism. This makes anticoagulants good choices for patients suffering from atrial fibrillation and those at high risk for stroke or other blood clot complications. However, this also inhibits the body from implementing self recovery mechanisms in cases of minor internal bleeding that can quickly become fatal under these conditions.

When warfarin had been the primary choice for anticoagulant patients, the risk of potentially fatal internal bleeding was present but could easily be mitigated by vitamin K. Warfarin patients, however, often had to get dose adjustments from their doctors; these patients were drawn to the convenience of Pradaxa’s single dose prescription feature.

By 2012, approximately 725,000 patients in the United States had started using Pradaxa.

The problem behind the drug is that Pradaxa did not have a reversal agent until 2015, which means that patients were exposed to the risk of uncontrollable Pradaxa bleeding for the initial five years of the drug’s market release. This spurred many patients to file legal action against Boehringer Ingelheim.

The company settled a major Pradaxa multidistrict litigation (MDL) in May 2014. Boehringer Ingelheim agreed to pay $650 million to settle 4,000 Pradaxa bleeding lawsuits. Patients who suffered uncontrollable bleeding injuries and were allegedly not warned about the potential Pradaxa bleeding risk may be eligible to file legal action against the company.