Pradaxa (dabigatran) is one of America’s most popular blood thinners, and is the first in the series of new generation anticoagulants meant to compete against warfarin (Coumadin).

Before the release of Pradaxa, there had not been a drug released to the American market for anticoagulant treatment purposes since warfarin in the 1960s.

However it was not long after Pradaxa’s release that numerous patients started reporting cases of serious internal bleeding.

Pradaxa and other blood thinners have become widely associated with internal bleeding. Internal bleeding is a potentially fatal medical condition in which bleeding occurs in different areas of the body such as the brain or the gastrointestinal tract.

Normally the body can stop internal bleeding on its own, but Pradaxa and other anticoagulants inhibit the body’s clotting ability. Some of the most serious Pradaxa internal bleeding injuries reported include gastrointestinal bleeding and brain hemorrhage.

Gastrointestinal bleeding occurs when a vessel or organ ruptures anywhere along the gastrointestinal tract. A brain hemorrhage can result in stroke. Patients who have suffered traumatic injuries or broken bones are at high risk, with elderly patients often having the highest risk.

Overview of Pradaxa Internal Bleeding

Typically prescribed to patients with atrial fibrillation or stroke risk, Pradaxa works by dilating the blood vessels in the body as well as inhibiting the body’s clotting mechanism. However this mechanism does not allow the body to recover from internal bleeding ruptures.

According to the Institute for Safe Medication Practices, over 307 adverse event reports of Pradaxa internal bleeding injuries were filed during the first three months the drug was on the market. This was 50% more than the number of warfarin injuries reported.

As the number of Pradaxa internal bleeding reports increased, the FDA issued a drug safety warning in December 2011 to address the issue. The agency stated that Pradaxa was being reviewed due to problems found in the post marketing reports.

At this point, Pradaxa internal bleeding events have lead to at least 260 deaths worldwide. Boehringer Ingelheim argues that Pradaxa is no more dangerous than warfarin based on the RE-LY clinical safety study. According to this safety study:

• 17.4% of Pradaxa patients required surgery to treat bleeding
• 16.4% of Pradaxa patients experienced bleeding
• 3.3% of Pradaxa patients experienced serious bleeding
• 1.5% of Pradaxa patients experienced life threatening bleeding
• 0.3% of Pradaxa patients experienced brain hemorrhage

Even with the severity of internal bleeding, Boehringer Ingelheim allegedly failed to warn customers that there was no reversal agent in the case of these side effects. In contrast, doctors can implement vitamin K in warfarin patients to stop the internal bleeding.

A number of Pradaxa patients have received compensation for their injuries due to recent Pradaxa settlements. However Pradaxa patients who have suffered injuries may be eligible to file legal action against the company and should consult a specialized lawyer.