Pradaxa (also known as dabigatran) is an anticoagulant medication manufactured by Boehringer Ingelheim Pharmaceuticals. It was developed as an alternative to the traditional blood thinner Warfarin. While Pradaxa’s maker claims that Pradaxa is easier to use than Warfarin, the drug has been at the center of several internal bleeding lawsuits for allegedly causing some patients to suffer from serious internal bleeding.

Background on Pradaxa

The U.S. Food and Drug Administration (FDA) approved Pradaxa in 2010 for use as an anticoagulant treatment, which can reduce a patient’s risk of stroke and blood clots. Anticoagulants are especially helpful for patients suffering from atrial fibrillation.

Pradaxa is part of a class of drugs known as Direct Thrombin Inhibitors. Boehringer marketed the blood thinner as superior to Warfarin (or Coumadin), as it supposedly does not require patients to undergo frequent monitoring, dose adjustment, or maintain a special diet.

However, despite these assurances, many reports have been filed concerning patients’ experiencing uncontrollable internal bleeding in their abdomens. Bleeding risks are an inherent feature of most anticoagulants, including Warfarin. The difference between Pradaxa patients and Warfarin patients is that Warfarin patients can be given Vitamin K to reverse the bleeding side effects, while those taking Pradaxa are left with no antidote to combat the dangerous and often fatal bleeding events.

Pradaxa Side Effects

Within just three months of landing on the U.S. pharmaceutical market, 307 adverse event reports were filed with the FDA regarding Pradaxa gastrointestinal bleeding, internal bleeding, and other complications. During its first year on the market, the federal agency received 260 Pradaxa death reports.

Some known side effects of Pradaxa include:

• Internal bleeding
• Kidney bleeding
• Gastrointestinal bleeding
• Heart attack
• Stroke
• Brain hemorrhage
• Death

Experts state that the reason Pradaxa is so deadly is because of the lack of a reversal agent. Should a patient experience a bleeding event, there is no way to combat the bleeding; a patient must wait until their body has flushed the drug out of their system, usually requiring several blood transfusions to survive.

As a result of these Pradaxa bleeding reports, the FDA issued a December 2011 drug notice, warning patients and medical professionals of the serious internal bleeding risks associated with the drug.

Pradaxa Litigation

Since the FDA warning, many Pradaxa lawsuits and a Pradaxa class action lawsuit have been filed in federal courts against Boehringer Ingelheim, alleging the pharmaceutical manufacturer misled patients and the medical community concerning the safety of their popular anticoagulant.

Additionally, many plaintiffs claim that Boehringer knew of the Pradaxa internal bleeding complications, but neglected to notify consumers via a drug warning on Pradaxa’s labeling, marketing, or packaging concerning the side effects.

If you or someone you know has suffered Pradaxa bleeding complications, you should consider speaking with a personal injury attorney to determine if you have grounds to file a Pradaxa lawsuit.