Pradaxa (dabigatran) bleeding complications have become a widespread concern among the patient population and the medical community due to reports of internal bleeding problems. Pradaxa irreversible bleeding can be potentially fatal.

Pradaxa is a part of the new generation anticoagulant drug family, which are meant to directly compete against each other and original blood thinner warfarin. Pradaxa is typically prescribed to patients suffering from atrial fibrillation and are at high risk for stroke, along with other blood clot injuries.

Pradaxa is manufactured by Boehringer Ingelheim.The FDA approved Pradaxa in 2010, which was the first drug approved by the agency for blood thinning treatment purposes since warfarin in the 1950s. It has since been prescribed to millions of patients

It was considered a landmark approval, and other pharmaceutical companies followed suit with their own entries into the anticoagulant market.

Pradaxa and other anticoagulants work by inhibiting the body’s clotting mechanism. However, this mechanism also prevents the body from recovering from internal bleeding injuries that might not have otherwise required any emergency measures.

Overview of Pradaxa Irreversible Bleeding Problems

Reports of Pradaxa irreversible bleeding have been reported since soon after its release. These reported problems have resulted in FDA warnings and substantial legal action against Boehringer Ingelheim.

Since the release of Pradaxa, there have been over 500 deaths related to Pradaxa irreversible bleeding reported to FDA. More adverse event reports were submitted in relation to Pradaxa than to hundreds of other drugs available at the same time.

This statistic was collected by the Institute for Safe Medication Practices, which noted that there were over 307 injury reports associated with Pradaxa irreversible bleeding injuries. The results indicate that Pradaxa had a 98.7% greater risk of internal bleeding, compared to other medications like warfarin.

In December 2011, the FDA issued a drug safety warning to the public and medical community regarding Pradaxa irreversible bleeding incidents. The agency warned that it was investigating the safety profile of Pradaxa after reviewing post-marketing reports.

Even though internal bleeding risks are associated with all anticoagulants, it was only recently that Praxbind, an approved bleeding antidote for Pradaxa, was approved. Pradaxa and other new generation anticoagulants gained popularity for their single dose prescription feature, compared to warfarin patients who need frequent adjustments.

However patients have reported cases of Pradaxa irreversible bleeding, and have needed emergency intervention to treat them. Even with the approval of Praxbind, it does not help patients who have already experienced adverse Pradaxa side effects.

Many former Pradaxa patients have filed legal action against Boehringer Ingelheim, for failing to warn them against Pradaxa irreversible bleeding.